Trial Outcomes & Findings for Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001) (NCT NCT03396445)

NCT ID: NCT03396445

Last Updated: 2025-11-05

Results Overview

DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs is reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

182 participants

Primary outcome timeframe

Up to 21 days in Cycle 1

Results posted on

2025-11-05

Participant Flow

Per protocol, pharmacokinetic (PK) outcome measures were not analyzed separately for the switch-over treatment arms.

Participant milestones

Participant milestones
Measure
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once every 6 weeks (Q6W) on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m\^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Treatment Period
Treated
3
3
6
3
8
2
14
3
3
3
7
14
30
15
13
10
41
0
0
0
0
0
0
0
0
0
Treatment Period
NOT COMPLETED
3
3
6
3
9
2
14
3
3
4
7
12
30
14
13
8
19
0
0
0
0
0
0
0
0
0
Switch-over Period
STARTED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
1
2
3
2
2
2
1
9
Switch-over Period
Treated
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
1
2
3
2
2
2
1
9
Switch-over Period
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
2
2
1
2
1
1
6
Treatment Period
STARTED
3
3
6
3
9
2
14
3
3
4
7
14
31
15
14
10
41
0
0
0
0
0
0
0
0
0
Treatment Period
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
2
1
1
1
2
22
0
0
0
0
0
0
0
0
0
Switch-over Period
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
1
1
0
1
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once every 6 weeks (Q6W) on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m\^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Treatment Period
Death
2
2
1
1
3
2
5
3
3
3
7
12
28
14
10
8
18
0
0
0
0
0
0
0
0
0
Treatment Period
Lost to Follow-up
0
0
0
0
0
0
0
0
0
0
0
0
1
0
1
0
0
0
0
0
0
0
0
0
0
0
Treatment Period
Physician Decision
0
0
0
0
1
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Treatment Period
Randomized by Mistake without Study Treatment
0
0
0
0
0
0
0
0
0
0
0
0
1
0
1
0
0
0
0
0
0
0
0
0
0
0
Treatment Period
Progressive Disease, Switched Over to Boserolimab + Pembrolizumab Combination Treatment
1
1
5
2
5
0
9
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Switch-over Period
Death
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
2
2
1
2
0
1
6
Switch-over Period
Lost to Follow-up
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
Treatment Period
Withdrawal by Subject
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
1
0
0
0
0
0
0
0
0
0

Baseline Characteristics

Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 Participants
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=2 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 2 mg Q3W
n=3 Participants
Participants received boserolimab 2 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 7 mg Q3W
n=3 Participants
Participants received boserolimab 7 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 20 mg Q3W
n=6 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=3 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=9 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=4 Participants
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 Participants
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 Participants
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=31 Participants
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=14 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)
n=10 Participants
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)
n=41 Participants
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m\^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Total
n=182 Participants
Total of all reporting groups
Age, Continuous
71.6 Years
STANDARD_DEVIATION 5.7 • n=8 Participants
61.0 Years
STANDARD_DEVIATION 2.8 • n=7 Participants
55.3 Years
STANDARD_DEVIATION 18.9 • n=15 Participants
57.3 Years
STANDARD_DEVIATION 18.0 • n=161 Participants
57.0 Years
STANDARD_DEVIATION 15.8 • n=100 Participants
54.0 Years
STANDARD_DEVIATION 15.7 • n=3 Participants
61.6 Years
STANDARD_DEVIATION 14.2 • n=8 Participants
44.7 Years
STANDARD_DEVIATION 15.6 • n=8 Participants
50.0 Years
STANDARD_DEVIATION 24.3 • n=8 Participants
61.5 Years
STANDARD_DEVIATION 6.2 • n=68 Participants
59.9 Years
STANDARD_DEVIATION 7.2 • n=4 Participants
55.1 Years
STANDARD_DEVIATION 16.1 • n=44 Participants
50.4 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
64.6 Years
STANDARD_DEVIATION 7.1 • n=20 Participants
68.5 Years
STANDARD_DEVIATION 9.5 • n=6 Participants
61.9 Years
STANDARD_DEVIATION 9.4 • n=1 Participants
51.7 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
57.5 Years
STANDARD_DEVIATION 13.6 • n=6 Participants
Sex: Female, Male
Female
14 Participants
n=8 Participants
2 Participants
n=7 Participants
2 Participants
n=15 Participants
1 Participants
n=161 Participants
2 Participants
n=100 Participants
2 Participants
n=3 Participants
5 Participants
n=8 Participants
2 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=68 Participants
7 Participants
n=4 Participants
10 Participants
n=44 Participants
31 Participants
n=5 Participants
15 Participants
n=20 Participants
14 Participants
n=6 Participants
6 Participants
n=1 Participants
41 Participants
n=7 Participants
155 Participants
n=6 Participants
Sex: Female, Male
Male
0 Participants
n=8 Participants
0 Participants
n=7 Participants
1 Participants
n=15 Participants
2 Participants
n=161 Participants
4 Participants
n=100 Participants
1 Participants
n=3 Participants
4 Participants
n=8 Participants
1 Participants
n=8 Participants
3 Participants
n=8 Participants
3 Participants
n=68 Participants
0 Participants
n=4 Participants
4 Participants
n=44 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=6 Participants
4 Participants
n=1 Participants
0 Participants
n=7 Participants
27 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
0 Participants
n=3 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=68 Participants
1 Participants
n=4 Participants
0 Participants
n=44 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
1 Participants
n=6 Participants
0 Participants
n=1 Participants
11 Participants
n=7 Participants
14 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=8 Participants
2 Participants
n=7 Participants
3 Participants
n=15 Participants
3 Participants
n=161 Participants
6 Participants
n=100 Participants
3 Participants
n=3 Participants
5 Participants
n=8 Participants
3 Participants
n=8 Participants
3 Participants
n=8 Participants
4 Participants
n=68 Participants
6 Participants
n=4 Participants
14 Participants
n=44 Participants
26 Participants
n=5 Participants
14 Participants
n=20 Participants
13 Participants
n=6 Participants
9 Participants
n=1 Participants
30 Participants
n=7 Participants
158 Participants
n=6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
0 Participants
n=3 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
00 Participants
n=8 Participants
0 Participants
n=68 Participants
0 Participants
n=4 Participants
0 Participants
n=44 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=6 Participants
0 Participants
n=1 Participants
0 Participants
n=7 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Asian
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
0 Participants
n=3 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=68 Participants
0 Participants
n=4 Participants
1 Participants
n=44 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=6 Participants
0 Participants
n=1 Participants
15 Participants
n=7 Participants
16 Participants
n=6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
0 Participants
n=3 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=68 Participants
0 Participants
n=4 Participants
0 Participants
n=44 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=6 Participants
0 Participants
n=1 Participants
0 Participants
n=7 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
0 Participants
n=3 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=68 Participants
0 Participants
n=4 Participants
0 Participants
n=44 Participants
0 Participants
n=5 Participants
2 Participants
n=20 Participants
0 Participants
n=6 Participants
0 Participants
n=1 Participants
0 Participants
n=7 Participants
3 Participants
n=6 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
0 Participants
n=3 Participants
3 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=68 Participants
0 Participants
n=4 Participants
0 Participants
n=44 Participants
1 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=6 Participants
0 Participants
n=1 Participants
0 Participants
n=7 Participants
4 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
0 Participants
n=3 Participants
3 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=68 Participants
0 Participants
n=4 Participants
0 Participants
n=44 Participants
5 Participants
n=5 Participants
1 Participants
n=20 Participants
0 Participants
n=6 Participants
1 Participants
n=1 Participants
0 Participants
n=7 Participants
10 Participants
n=6 Participants
Race (NIH/OMB)
White
13 Participants
n=8 Participants
2 Participants
n=7 Participants
3 Participants
n=15 Participants
3 Participants
n=161 Participants
6 Participants
n=100 Participants
3 Participants
n=3 Participants
6 Participants
n=8 Participants
3 Participants
n=8 Participants
3 Participants
n=8 Participants
4 Participants
n=68 Participants
7 Participants
n=4 Participants
13 Participants
n=44 Participants
30 Participants
n=5 Participants
13 Participants
n=20 Participants
14 Participants
n=6 Participants
10 Participants
n=1 Participants
26 Participants
n=7 Participants
159 Participants
n=6 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=8 Participants
0 Participants
n=7 Participants
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
0 Participants
n=3 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=68 Participants
0 Participants
n=4 Participants
0 Participants
n=44 Participants
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=6 Participants
0 Participants
n=1 Participants
0 Participants
n=7 Participants
0 Participants
n=6 Participants

PRIMARY outcome

Timeframe: Up to 21 days in Cycle 1

Population: All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment and who were observed for DLTs for up to 21 days following the first dose of study treatment in Cycle 1. As pre-specified in the protocol, DLTs were analyzed separately for the Switch-over Arms.

DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs is reported.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=3 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=3 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
n=6 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=3 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=8 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=2 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 Participants
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 Participants
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 Participants
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=30 Participants
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=13 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=3 Participants
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
n=9 Participants
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Up to approximately 78 months

Population: All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment. As pre-specified in the protocol, safety data were analyzed separately for the Switch-over Arms.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced one or more AEs is reported.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=3 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=3 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
n=6 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=3 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=8 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=2 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 Participants
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 Participants
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 Participants
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=30 Participants
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=13 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=3 Participants
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
n=9 Participants
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Number of Participants With One or More AEs
3 Participants
3 Participants
6 Participants
3 Participants
8 Participants
2 Participants
14 Participants
3 Participants
7 Participants
14 Participants
30 Participants
15 Participants
13 Participants
3 Participants
3 Participants
1 Participants
1 Participants
2 Participants
3 Participants
2 Participants
2 Participants
2 Participants
1 Participants
8 Participants

PRIMARY outcome

Timeframe: Up to 23 months

Population: All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment. As pre-specified in the protocol, safety data were analyzed separately for the Switch-over Arms.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE is reported.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=3 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=3 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
n=6 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=3 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=8 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=2 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 Participants
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 Participants
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 Participants
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=30 Participants
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=13 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=3 Participants
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
n=2 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
n=1 Participants
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
n=9 Participants
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Number of Participants Who Discontinued Study Treatment Due to an AE
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
1 Participants
1 Participants
4 Participants
1 Participants
2 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants

SECONDARY outcome

Timeframe: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2

Population: All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-last data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.

AUC0-last was defined as the area under the concentration versus time curve for boserolimab from 0 to the time of the last quantifiable concentration in serum. Samples were taken predose and at specified times postdose to determine the AUC0-last of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=3 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=1 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
n=3 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=3 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=8 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=2 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 Participants
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=2 Participants
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 Participants
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 Participants
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=30 Participants
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=11 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=2 Participants
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=10 Participants
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=40 Participants
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab
0.761 day*μg/mL
Geometric Coefficient of Variation 179
7.61 day*μg/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n=1.
44.4 day*μg/mL
Geometric Coefficient of Variation 28.6
150 day*μg/mL
Geometric Coefficient of Variation 14.2
469 day*μg/mL
Geometric Coefficient of Variation 42.9
918 day*μg/mL
Geometric Coefficient of Variation 21.4
44.4 day*μg/mL
Geometric Coefficient of Variation 51.7
26.1 day*μg/mL
Geometric Coefficient of Variation 38.5
84.5 day*μg/mL
Geometric Coefficient of Variation 192
646 day*μg/mL
Geometric Coefficient of Variation 16.3
41.5 day*μg/mL
Geometric Coefficient of Variation 109
44.9 day*μg/mL
Geometric Coefficient of Variation 68.6
47.5 day*μg/mL
Geometric Coefficient of Variation 58.5
0.816 day*μg/mL
Geometric Coefficient of Variation 20.8
3.9 day*μg/mL
Geometric Coefficient of Variation 117
41.6 day*μg/mL
Geometric Coefficient of Variation 44.5
62.9 day*μg/mL
Geometric Coefficient of Variation 57.8

SECONDARY outcome

Timeframe: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2

Population: All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-3w data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.

AUC0-3w was defined as the area under the concentration versus time curve for boserolimab from 0 to 3 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-3w of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=3 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=1 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
n=3 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=3 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=8 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=2 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 Participants
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=2 Participants
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 Participants
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 Participants
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=30 Participants
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=11 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=2 Participants
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=10 Participants
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=40 Participants
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Area Under the Concentration-Time Curve From Time 0 to 3 Weeks (AUC0-3w) of Boserolimab
1.79 day*μg/mL
Geometric Coefficient of Variation 111
7.77 day*μg/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n = 1
44.4 day*μg/mL
Geometric Coefficient of Variation 28.6
155 day*μg/mL
Geometric Coefficient of Variation 7.85
531 day*μg/mL
Geometric Coefficient of Variation 28.1
1060 day*μg/mL
Geometric Coefficient of Variation 0.434
44.3 day*μg/mL
Geometric Coefficient of Variation 54
28.1 day*μg/mL
Geometric Coefficient of Variation 50.8
142 day*μg/mL
Geometric Coefficient of Variation 63.3
661 day*μg/mL
Geometric Coefficient of Variation 16.4
49.9 day*μg/mL
Geometric Coefficient of Variation 41.3
50.5 day*μg/mL
Geometric Coefficient of Variation 34.2
48.1 day*μg/mL
Geometric Coefficient of Variation 42.5
1.2 day*μg/mL
Geometric Coefficient of Variation 22
6.69 day*μg/mL
Geometric Coefficient of Variation 47.5
42.2 day*μg/mL
Geometric Coefficient of Variation 41.5
60.4 day*μg/mL
Geometric Coefficient of Variation 39.5

SECONDARY outcome

Timeframe: Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 Cycle 2

Population: All participants in Arms 2c and 4 who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-6w data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.

AUC0-6w was defined as the area under the concentration versus time curve for boserolimab from 0 to 6 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-6w of boserolimab. As pre-specified in the protocol, different arms had different sampling schedules and cycle lengths and therefore AUC0-6w was not analyzed for all Arms; AUC0-6w was only analyzed for Arms 2c and 4 which had 6-week cycles.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=11 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=40 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Area Under the Concentration-Time Curve From Time 0 to 6 Weeks (AUC0-6w) of Boserolimab
55 day*μg/mL
Geometric Coefficient of Variation 49.2
68.3 day*μg/mL
Geometric Coefficient of Variation 45.4

SECONDARY outcome

Timeframe: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2

Population: All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available Cmin data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.

Cmin of boserolimab was defined as the minimum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmin of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=3 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=2 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
n=3 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=2 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=5 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=1 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=13 Participants
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=5 Participants
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=13 Participants
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=26 Participants
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=10 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=2 Participants
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=2 Participants
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=9 Participants
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=36 Participants
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Minimum Concentration (Cmin) of Boserolimab
NA μg/mL
Standard Deviation NA
For all 3 participants, plasma concentrations of boserolimab were below the limits of quantitation.
0.0689 μg/mL
Standard Deviation 0.0975
0.421 μg/mL
Standard Deviation 0.103
3.55 μg/mL
Standard Deviation 0.573
15.5 μg/mL
Standard Deviation 8.08
24.3 μg/mL
Standard Deviation NA
Method of dispersion could not be estimated due to n = 1
0.617 μg/mL
Standard Deviation 0.498
0.0629 μg/mL
Standard Deviation 0.0575
3.55 μg/mL
Standard Deviation 3.37
16.2 μg/mL
Standard Deviation 5.14
0.721 μg/mL
Standard Deviation 0.505
0.610 μg/mL
Standard Deviation 0.499
0.126 μg/mL
Standard Deviation 0.258
NA μg/mL
Standard Deviation NA
For all 2 participants, plasma concentrations of boserolimab were below the limits of quantitation.
0.0283 μg/mL
Standard Deviation 0.0400
0.471 μg/mL
Standard Deviation 0.473
0.158 μg/mL
Standard Deviation 0.340

SECONDARY outcome

Timeframe: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2

Population: All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available Cmax data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.

Cmax of boserolimab was defined as the maximum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmax of boserolimab. PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=3 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=1 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
n=3 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=3 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=8 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=2 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 Participants
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=2 Participants
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 Participants
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 Participants
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=30 Participants
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=11 Participants
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=2 Participants
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 Participants
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=10 Participants
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=40 Participants
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Maximum Concentration (Cmax) of Boserolimab
1.15 μg/mL
Geometric Coefficient of Variation 175
3.32 μg/mL
Geometric Coefficient of Variation NA
Method of dispersion could not be estimated due to n = 1
8.16 μg/mL
Geometric Coefficient of Variation 28.6
21.6 μg/mL
Geometric Coefficient of Variation 22
67.8 μg/mL
Geometric Coefficient of Variation 23.1
105 μg/mL
Geometric Coefficient of Variation 8.71
7.24 μg/mL
Geometric Coefficient of Variation 46.7
4.9 μg/mL
Geometric Coefficient of Variation 39
26.9 μg/mL
Geometric Coefficient of Variation 37
83.2 μg/mL
Geometric Coefficient of Variation 16.6
7.89 μg/mL
Geometric Coefficient of Variation 70.2
8.68 μg/mL
Geometric Coefficient of Variation 24.6
8.27 μg/mL
Geometric Coefficient of Variation 37.4
0.656 μg/mL
Geometric Coefficient of Variation 5.08
1.75 μg/mL
Geometric Coefficient of Variation 5.75
7.44 μg/mL
Geometric Coefficient of Variation 37.3
9.39 μg/mL
Geometric Coefficient of Variation 33.2

SECONDARY outcome

Timeframe: Up to approximately 78 months

Population: All participants in Arm 1a, 2a, 2b, 2c, 4, and Switch-over Arm 1a with a baseline scan who demonstrated measurable disease by investigator assessment, and who were administered at least 1 dose of study treatment.

ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. As pre-specified in the protocol, ORR was analyzed for participants treated with boserolimab when used as monotherapy in Arm 1a, in combination with pembrolizumab in Switch-over Arm 1a and Arms 2a, 2b, and 2c, or in combination with pembrolizumab + nab-paclitaxel in Arm 4. Per protocol, ORR was not analyzed in Arms 1, 2, or 3. The percentage of participants who experienced a CR or PR, as assessed by the investigator, is reported.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=14 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=30 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
n=15 Participants
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
n=13 Participants
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=41 Participants
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
n=9 Participants
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
7.1 Percentage of Participants
Interval 0.2 to 33.9
20.0 Percentage of Participants
Interval 7.7 to 38.6
13.3 Percentage of Participants
Interval 1.7 to 40.5
0.0 Percentage of Participants
Interval 0.0 to 24.7
53.7 Percentage of Participants
Interval 37.4 to 69.3
11.1 Percentage of Participants
Interval 0.3 to 48.2

SECONDARY outcome

Timeframe: Up to 21 days in Cycle 1

Population: All participants in Arm 3 who received ≥1 dose of study treatment and who were observed for DLTs for up to 21 days following the first dose of study treatment in Cycle 1.

DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 3 is reported

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=10 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Arm 3: Number of Participants Who Experienced a DLT
0 Participants

SECONDARY outcome

Timeframe: Up to 28 days in Cycle 1

Population: All participants in Arm 4 who received ≥1 dose of study treatment and who were observed for DLTs for up to 28 days following the first dose of study treatment in Cycle 1.

DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 4 is reported.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=41 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Arm 4: Number of Participants Who Experienced a DLT
1 Participants

SECONDARY outcome

Timeframe: Up to 57 months

Population: All participants in Arms 3 or 4 who received ≥1 dose of study treatment.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 and 4 who experienced one or more AEs is reported.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=10 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=41 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Arm 3 and 4: Number of Participants With One or More AEs
10 Participants
41 Participants

SECONDARY outcome

Timeframe: Up to 27 months

Population: All participants in Arms 3 or 4 who received ≥1 dose of study treatment.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 or 4 who discontinued study treatment due to an AE is reported.

Outcome measures

Outcome measures
Measure
Arm 1 Boserolimab 2 mg Q3W
n=10 Participants
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 7 mg Q3W
n=41 Participants
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Arm 3 and 4: Number of Participants Who Discontinued Study Treatment Due to an AE
2 Participants
6 Participants

Adverse Events

Arm 1 Boserolimab 700 mg Q3W

Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths

Arm 1 Boserolimab 2 mg Q3W

Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths

Arm 1 Boserolimab 7 mg Q3W

Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths

Arm 1 Boserolimab 20 mg Q3W

Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths

Arm 1 Boserolimab 70 mg Q3W

Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths

Arm 1 Boserolimab 200 mg Q3W

Serious events: 1 serious events
Other events: 8 other events
Deaths: 3 deaths

Arm 1a Boserolimab 30 mg Q3W (Endometrial)

Serious events: 2 serious events
Other events: 14 other events
Deaths: 5 deaths

Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W

Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths

Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W

Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths

Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W

Serious events: 1 serious events
Other events: 3 other events
Deaths: 4 deaths

Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W

Serious events: 1 serious events
Other events: 7 other events
Deaths: 7 deaths

Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W

Serious events: 3 serious events
Other events: 14 other events
Deaths: 12 deaths

Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)

Serious events: 11 serious events
Other events: 30 other events
Deaths: 29 deaths

Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)

Serious events: 2 serious events
Other events: 15 other events
Deaths: 14 deaths

Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)

Serious events: 0 serious events
Other events: 13 other events
Deaths: 10 deaths

Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)

Serious events: 9 serious events
Other events: 10 other events
Deaths: 8 deaths

Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)

Serious events: 13 serious events
Other events: 40 other events
Deaths: 18 deaths

Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W

Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths

Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W

Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths

Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W

Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths

Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W

Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths

Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W

Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths

Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W

Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths

Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W

Serious events: 3 serious events
Other events: 8 other events
Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure
Arm 1 Boserolimab 700 mg Q3W
n=2 participants at risk
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 2 mg Q3W
n=3 participants at risk
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 7 mg Q3W
n=3 participants at risk
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 20 mg Q3W
n=6 participants at risk
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 70 mg Q3W
n=3 participants at risk
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=8 participants at risk
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 participants at risk
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 participants at risk
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 participants at risk
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 participants at risk
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 participants at risk
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 participants at risk
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=30 participants at risk
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 participants at risk
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=13 participants at risk
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)
n=10 participants at risk
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)
n=41 participants at risk
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m\^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 participants at risk
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 participants at risk
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
n=2 participants at risk
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=3 participants at risk
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 participants at risk
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 participants at risk
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
n=2 participants at risk
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
n=1 participants at risk
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
n=9 participants at risk
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Cardiac disorders
Pericarditis constrictive
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Endocrine disorders
Adrenal insufficiency
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Endocrine disorders
Inappropriate antidiuretic hormone secretion
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Endocrine disorders
Thyroiditis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Abdominal pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Constipation
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Diarrhoea
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Immune-mediated gastritis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Chest pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Complication associated with device
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Fatigue
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Malaise
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Oedema peripheral
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Pyrexia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Sudden death
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Hepatobiliary disorders
Cholecystitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Hepatobiliary disorders
Hepatic haemorrhage
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Immune system disorders
Cytokine release syndrome
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
COVID-19
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
COVID-19 pneumonia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Cellulitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Cystitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Pneumonia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Pneumonia bacterial
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Pulmonary sepsis
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Respiratory tract infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Wound infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Multiple fractures
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Post procedural haematuria
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Neutrophil count decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Platelet count decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
White blood cell count decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Ataxia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Encephalitis autoimmune
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Epilepsy
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Hemiparesis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Myasthenia gravis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Acute kidney injury
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Haematuria
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Tubulointerstitial nephritis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
3/30 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Hypotension
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Lymphoedema
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Thrombosis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.

Other adverse events

Other adverse events
Measure
Arm 1 Boserolimab 700 mg Q3W
n=2 participants at risk
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 2 mg Q3W
n=3 participants at risk
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 7 mg Q3W
n=3 participants at risk
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 20 mg Q3W
n=6 participants at risk
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 1 Boserolimab 70 mg Q3W
n=3 participants at risk
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1 Boserolimab 200 mg Q3W
n=8 participants at risk
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
n=14 participants at risk
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 participants at risk
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 participants at risk
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W
n=3 participants at risk
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W
n=7 participants at risk
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W
n=14 participants at risk
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)
n=30 participants at risk
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)
n=15 participants at risk
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)
n=13 participants at risk
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)
n=10 participants at risk
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)
n=41 participants at risk
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m\^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 participants at risk
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
n=1 participants at risk
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
n=2 participants at risk
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=3 participants at risk
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 participants at risk
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
n=2 participants at risk
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
n=2 participants at risk
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
n=1 participants at risk
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
n=9 participants at risk
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Blood and lymphatic system disorders
Anaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
5/10 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
43.9%
18/41 • Number of events 54 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.0%
9/41 • Number of events 60 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
24.4%
10/41 • Number of events 65 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
40.0%
4/10 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Blood and lymphatic system disorders
Thrombocytosis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Cardiac disorders
Palpitations
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Cardiac disorders
Sinus tachycardia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
5/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Ear and labyrinth disorders
Ear pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Ear and labyrinth disorders
Tinnitus
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Ear and labyrinth disorders
Vertigo
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Ear and labyrinth disorders
Vertigo positional
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Endocrine disorders
Autoimmune thyroiditis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Endocrine disorders
Cushingoid
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Endocrine disorders
Hyperthyroidism
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
4/30 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Endocrine disorders
Hypothyroidism
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
17.1%
7/41 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Dry eye
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Eye discharge
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Eyelid oedema
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Keratitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Lacrimation increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Scleral disorder
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Ulcerative keratitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Vision blurred
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Visual impairment
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Eye disorders
Vitreous floaters
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Abdominal distension
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Abdominal pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
3/6 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
4/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Anal incontinence
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Ascites
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Constipation
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
21.4%
3/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
5/30 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
31.7%
13/41 • Number of events 19 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.2%
2/9 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Diarrhoea
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
37.5%
3/8 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
3/30 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
40.0%
6/15 • Number of events 10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
5/10 • Number of events 9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
43.9%
18/41 • Number of events 45 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Dry mouth
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Dyspepsia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
19.5%
8/41 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Dysphagia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Faeces soft
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Flatulence
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Frequent bowel movements
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Gastrointestinal obstruction
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Gastrointestinal pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Glossodynia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Hiatus hernia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Nausea
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
4/6 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
25.0%
2/8 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
40.0%
12/30 • Number of events 16 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
26.7%
4/15 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
38.5%
5/13 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
5/10 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
53.7%
22/41 • Number of events 33 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Odynophagia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Oral dysaesthesia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Oral pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Proctalgia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Rectal tenesmus
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Stomatitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
29.3%
12/41 • Number of events 26 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Tongue disorder
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Gastrointestinal disorders
Vomiting
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
4/6 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
9/30 • Number of events 13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
26.8%
11/41 • Number of events 15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Asthenia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
3/15 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Axillary pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Chest pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Chills
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
28.6%
4/14 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
40.0%
12/30 • Number of events 13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Face oedema
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Fatigue
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
3/6 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
21.4%
3/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
85.7%
6/7 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
64.3%
9/14 • Number of events 10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
60.0%
18/30 • Number of events 20 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
26.7%
4/15 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
23.1%
3/13 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
60.0%
6/10 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
61.0%
25/41 • Number of events 41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Feeling of body temperature change
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
General physical health deterioration
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Influenza like illness
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
25.0%
2/8 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
26.7%
8/30 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Infusion site extravasation
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Localised oedema
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Malaise
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Mucosal inflammation
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Non-cardiac chest pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Oedema
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.6%
6/41 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Oedema peripheral
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
26.7%
4/15 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.6%
6/41 • Number of events 10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Peripheral swelling
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Pyrexia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
3/3 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
21.4%
3/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
56.7%
17/30 • Number of events 25 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.0%
9/41 • Number of events 9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Swelling face
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
General disorders
Xerosis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.6%
6/41 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Hepatobiliary disorders
Hypertransaminasaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Abscess
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Asymptomatic bacteriuria
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Body tinea
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
COVID-19
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
24.4%
10/41 • Number of events 11 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.2%
2/9 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Cellulitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Conjunctivitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Cystitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Device related infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Eye infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Genital infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Herpes ophthalmic
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Herpes zoster
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
3/3 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Lip infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Lower respiratory tract infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Mucosal infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Nasopharyngitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
24.4%
10/41 • Number of events 15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Oral candidiasis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Oral infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Otitis externa
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Pharyngitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Pneumonia
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
40.0%
4/10 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Respiratory tract infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Respiratory tract infection viral
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Rhinitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Sinusitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Skin infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Upper respiratory tract infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Urinary tract infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.2%
2/9 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Vascular device infection
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Infections and infestations
Vulvovaginal candidiasis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Arthropod sting
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Bone contusion
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Contusion
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Infusion related reaction
100.0%
2/2 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
42.9%
6/14 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
28.6%
4/14 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
10/30 • Number of events 11 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
26.7%
4/15 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
38.5%
5/13 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
3/9 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Radiation necrosis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Alanine aminotransferase increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
6/30 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
34.1%
14/41 • Number of events 27 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Amylase increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
26.8%
11/41 • Number of events 23 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Aspartate aminotransferase increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
5/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
23.1%
3/13 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
36.6%
15/41 • Number of events 26 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood albumin decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood alkaline phosphatase increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood bilirubin increased
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood calcium decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood cholesterol increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood creatinine increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood glucose increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood iron decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood potassium decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood sodium decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood sodium increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Blood uric acid increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Cardiac murmur
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Haemoglobin decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Lipase increased
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
36.6%
15/41 • Number of events 38 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Lymphocyte count decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Neutrophil count decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
40.0%
4/10 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
31.7%
13/41 • Number of events 35 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Platelet count decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
40.0%
4/10 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
SARS-CoV-2 test positive
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Serum ferritin decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Transaminases increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Weight decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.6%
6/41 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
Weight increased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Investigations
White blood cell count decreased
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
40.0%
4/10 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
3/30 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
24.4%
10/41 • Number of events 13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.2%
2/9 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Dehydration
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.6%
6/41 • Number of events 13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hypernatraemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hyperphosphataemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hypokalaemia
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Hypophosphataemia
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Metabolism and nutrition disorders
Iron deficiency
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
5/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.0%
9/41 • Number of events 16 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
2/2 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
5/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.0%
9/41 • Number of events 9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Coccydynia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Joint stiffness
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
3/30 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
19.5%
8/41 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
2/6 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
4/30 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
3/15 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
41.5%
17/41 • Number of events 22 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Myalgia intercostal
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
5/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
3/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
3/15 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Musculoskeletal and connective tissue disorders
Vertebral column mass
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
3/15 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Bell's palsy
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Dizziness
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
6/30 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.0%
9/41 • Number of events 9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Dysgeusia
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.6%
6/41 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Headache
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
42.9%
3/7 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
5/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
29.3%
12/41 • Number of events 15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Loss of consciousness
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Neuropathy peripheral
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Paraesthesia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
39.0%
16/41 • Number of events 17 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Psychomotor hyperactivity
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Radiculopathy
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Somnolence
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
Taste disorder
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Nervous system disorders
VIth nerve paresis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Psychiatric disorders
Anxiety
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Psychiatric disorders
Depression
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Psychiatric disorders
Insomnia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
17.1%
7/41 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Acute kidney injury
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Chronic kidney disease
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Dysuria
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Haematuria
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Hydronephrosis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Pollakiuria
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Urinary incontinence
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Urinary retention
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Urinary tract pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Renal and urinary disorders
Urogenital fistula
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Reproductive system and breast disorders
Breast inflammation
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Reproductive system and breast disorders
Breast pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Reproductive system and breast disorders
Coital bleeding
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Reproductive system and breast disorders
Vaginal discharge
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Reproductive system and breast disorders
Vaginal haemorrhage
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Reproductive system and breast disorders
Vulvovaginal discomfort
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
21.4%
3/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
4/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
31.7%
13/41 • Number of events 19 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.2%
2/9 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
6/30 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.3%
3/41 • Number of events 8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
4.9%
2/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
3/30 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
48.8%
20/41 • Number of events 20 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
4/30 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.5%
1/8 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Macule
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Nail disorder
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Papule
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
25.0%
2/8 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
21.4%
3/14 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
28.6%
2/7 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
7/14 • Number of events 7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
36.7%
11/30 • Number of events 11 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
53.7%
22/41 • Number of events 29 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
66.7%
2/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
22.2%
2/9 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
20.0%
2/10 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
41.5%
17/41 • Number of events 27 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
50.0%
1/2 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
9.8%
4/41 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
25.0%
2/8 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
21.4%
3/14 • Number of events 4 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
5/30 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
26.7%
4/15 • Number of events 5 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
30.0%
3/10 • Number of events 3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
19.5%
8/41 • Number of events 12 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
2/2 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
100.0%
1/1 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
10.0%
1/10 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Scar pain
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
16.7%
1/6 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Skin burning sensation
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Skin lesion
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Skin reaction
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
13.3%
2/15 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Deep vein thrombosis
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Embolism
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Flushing
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.7%
1/13 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Haematoma
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Hot flush
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Hypertension
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
2/14 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
33.3%
1/3 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
3.3%
1/30 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
15.4%
2/13 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
12.2%
5/41 • Number of events 10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Hypotension
50.0%
1/2 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
2/30 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Lymphoedema
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
14.3%
1/7 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
2.4%
1/41 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
11.1%
1/9 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Peripheral coldness
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
6.7%
1/15 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
Vascular disorders
Vena cava embolism
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/6 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/8 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
7.1%
1/14 • Number of events 1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/7 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/14 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/30 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/15 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/13 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/10 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/41 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/3 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/2 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/1 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
0.00%
0/9 • Up to approximately 78 months
Serious \& other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Results disclosure agreements

  • Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial prior to submission. Any information identified by the Sponsor as confidential must be deleted prior to submission. This confidentiality does not include efficacy and safety results. The Sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the Sponsor will generally support publication.
  • Publication restrictions are in place

Restriction type: OTHER