Trial Outcomes & Findings for DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01] (NCT NCT03329690)
NCT ID: NCT03329690
Last Updated: 2022-03-18
Results Overview
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
233 participants
Primary outcome timeframe
Baseline to date of first documented objective response (CR or PR), up to 36 months postdose
Results posted on
2022-03-18
Participant Flow
In the Primary Cohort, a total of 188 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to treatment. In the Exploratory Cohorts, a total of 45 non-randomized participants were enrolled and 44 patients received treatment. Study participants for all cohorts were enrolled at clinic sites in South Korea and Japan. Participants took part of the study from November 2, 2017 to Data Cut-Off (DCO) date of December 11, 2020.
In the Primary Cohort, participants with HER2 overexpressing gastric of GEJ adenocarcinoma were randomized (2:1) to either DS-8201a or physician's choice (irinotecan or paclitaxel). In the Exploratory Cohorts, participants with HER2 IHC 2+/ISH negative advanced gastric or GEJ adenocarcinoma who were naïve to HER2 treatment received DS-8201a.
Participant milestones
| Measure |
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
126
|
55
|
7
|
21
|
24
|
|
Overall Study
Received Treatment
|
125
|
55
|
7
|
20
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
126
|
55
|
7
|
21
|
24
|
Reasons for withdrawal
| Measure |
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive disease per RECIST
|
85
|
44
|
6
|
16
|
20
|
|
Overall Study
Clinical progression
|
7
|
4
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
22
|
4
|
0
|
1
|
2
|
|
Overall Study
Death
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Miscellaneous
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
Did not receive treatment
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
Baseline characteristics by cohort
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=20 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=24 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
110 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
70 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
121 Participants
n=8 Participants
|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 10.54 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 10.87 • n=4 Participants
|
55.5 years
STANDARD_DEVIATION 12.12 • n=21 Participants
|
63.3 years
STANDARD_DEVIATION 10.86 • n=8 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
56 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
175 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
125 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
231 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
South Korea
|
26 participants
n=5 Participants
|
11 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
47 participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
99 participants
n=5 Participants
|
44 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
19 participants
n=21 Participants
|
184 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to date of first documented objective response (CR or PR), up to 36 months postdosePopulation: Objective response rate was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.
Outcome measures
| Measure |
DS-8201a
n=126 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed ORR, 25 months (DCO: Nov 8, 2019)
|
51 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed ORR, 25 months (DCO: Nov 8, 2019)
|
61 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed ORR, 36 months (DCO: Dec 11, 2020)
|
61 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed ORR, 36 months (DCO: Dec 11, 2020)
|
50 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to date of first documented objective response, up to 36 months postdosePopulation: Best overall response was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.
The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported.
Outcome measures
| Measure |
DS-8201a
n=126 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
|
50 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
|
46 Participants
|
27 Participants
|
3 Participants
|
30 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
|
15 Participants
|
18 Participants
|
0 Participants
|
18 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
|
4 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
|
55 Participants
|
28 Participants
|
3 Participants
|
31 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
|
57 Participants
|
28 Participants
|
3 Participants
|
31 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
|
15 Participants
|
18 Participants
|
0 Participants
|
18 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
|
15 Participants
|
18 Participants
|
0 Participants
|
18 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
|
5 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
|
4 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
|
51 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
|
47 Participants
|
27 Participants
|
3 Participants
|
30 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
|
15 Participants
|
18 Participants
|
0 Participants
|
18 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
|
9 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
|
41 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
|
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
|
41 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of death (due to any cause), up to 36 months postdosePopulation: Duration of survival and overall survival were assessed in the Intent-to-Treat Analysis Set.
Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause.
Outcome measures
| Measure |
DS-8201a
n=126 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=21 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=22 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Duration of survival follow up, 25 months (DCO: Nov 8, 2019)
|
8.0 months
Interval 0.4 to 23.1
|
7.1 months
Interval 0.3 to 20.3
|
5.5 months
Interval 2.0 to 14.3
|
7.0 months
Interval 0.3 to 20.3
|
7.3 months
Interval 0.2 to 19.6
|
8.4 months
Interval 1.8 to 14.8
|
|
Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Overall survival, 25 months (DCO: Nov 8, 2019)
|
12.5 months
Interval 0.4 to 23.1
|
8.4 months
Interval 0.3 to 20.3
|
14.3 months
Interval 2.0 to 14.3
|
8.4 months
Interval 0.3 to 20.3
|
7.8 months
Interval 0.2 to 19.6
|
8.5 months
Interval 1.8 to 14.8
|
|
Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Overall survival, 36 months (DCO: Dec 11, 2020)
|
12.6 months
Interval 0.4 to 33.2
|
8.6 months
Interval 0.3 to 29.3
|
14.3 months
Interval 2.0 to 22.1
|
8.9 months
Interval 0.3 to 29.3
|
7.8 months
Interval 0.2 to 27.7
|
8.5 months
Interval 1.8 to 23.1
|
|
Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Duration of survival follow up, 36 months (DCO: Dec 11, 2020)
|
12.3 months
Interval 0.4 to 33.2
|
8.4 months
Interval 0.3 to 29.3
|
14.3 months
Interval 2.0 to 22.1
|
8.5 months
Interval 0.3 to 29.3
|
7.3 months
Interval 0.2 to 27.7
|
8.5 months
Interval 1.8 to 23.1
|
SECONDARY outcome
Timeframe: From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdosePopulation: Progression-free survival (PFS) was assessed in the Intent-to-Treat Analysis Set.
Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
DS-8201a
n=126 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=21 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=22 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
PFS, 25 months (DCO: Nov 8, 2019)
|
5.6 months
Interval 4.3 to 6.9
|
2.8 months
Interval 2.0 to 4.3
|
4.9 months
Interval 2.0 to
Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity.
|
3.5 months
Interval 2.0 to 4.3
|
4.4 months
Interval 2.7 to 7.1
|
2.8 months
Interval 1.5 to 4.3
|
|
Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
PFS, 36 months (DCO: Dec 11, 2020)
|
5.6 months
Interval 4.3 to 6.9
|
2.8 months
Interval 2.0 to 4.3
|
4.9 months
Interval 2.0 to
Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity.
|
3.5 months
Interval 2.0 to 4.3
|
4.4 months
Interval 2.7 to 7.1
|
2.8 months
Interval 1.5 to 4.3
|
SECONDARY outcome
Timeframe: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdosePopulation: Duration of response (DOR) was assessed in the Full Analysis Set.
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
Outcome measures
| Measure |
DS-8201a
n=61 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=1 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=8 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=7 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=4 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019)
|
8.4 months
Interval 0.0 to 21.0
|
4.1 months
Interval 0.0 to 4.9
|
3.9 months
Interval 3.9 to 3.9
|
3.9 months
Interval 0.0 to 4.9
|
6.8 months
Interval 1.4 to 9.7
|
7.1 months
Interval 1.4 to 12.5
|
|
Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020)
|
11.3 months
Interval 0.0 to 29.1
|
4.1 months
Interval 0.0 to 4.9
|
3.9 months
Interval 3.9 to 3.9
|
3.9 months
Interval 0.0 to 4.9
|
6.8 months
Interval 1.4 to 12.5
|
5.8 months
Interval 1.4 to 12.5
|
|
Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020)
|
12.7 months
Interval 1.4 to 29.1
|
4.1 months
Interval 1.4 to 4.9
|
3.9 months
Interval 3.9 to 3.9
|
3.9 months
Interval 1.4 to 4.9
|
7.6 months
Interval 2.4 to 12.5
|
11.2 months
Interval 10.0 to 12.5
|
|
Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019)
|
11.3 months
Interval 1.4 to 21.0
|
4.1 months
Interval 1.4 to 4.9
|
3.9 months
Interval 3.9 to 3.9
|
3.9 months
Interval 1.4 to 4.9
|
7.6 months
Interval 2.4 to 9.7
|
12.5 months
Interval 8.1 to 12.5
|
SECONDARY outcome
Timeframe: Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdosePopulation: Disease control rate (DCR) was assessed in the Intent-to-Treat Set.
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
DS-8201a
n=126 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=21 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=22 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
DCR, 25 months (DCO: Nov 8, 2019)
|
107 Participants
|
34 Participants
|
4 Participants
|
38 Participants
|
17 Participants
|
15 Participants
|
|
Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
DCR, 36 months (DCO: Dec 11, 2020)
|
108 Participants
|
34 Participants
|
4 Participants
|
38 Participants
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From randomization to first documented objective response, up to 36 months postdosePopulation: Best overall response was assessed in the Exploratory Cohorts in the Intent-to-Treat Analysis Set.
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Independent Central Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported.
Outcome measures
| Measure |
DS-8201a
n=21 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=22 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019)
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Inevaluable, 25 months (DCO: Nov 8, 2019)
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Inevaluable, 36 months (DCO: Dec 11, 2020)
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020)
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdosePopulation: Time to treatment failure (TTF) was assessed in the Full Analysis Set.
Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation.
Outcome measures
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=20 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=22 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
TTF, 36 months (DCO: Dec 11, 2020)
|
4.3 months
Interval 3.9 to 5.4
|
2.6 months
Interval 1.6 to 2.8
|
2.9 months
Interval 1.1 to 6.8
|
2.6 months
Interval 1.6 to 2.8
|
3.7 months
Interval 1.7 to 5.5
|
2.2 months
Interval 1.4 to 3.0
|
|
Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
TTF, 25 months (DCO: Nov 8, 2019)
|
4.2 months
Interval 3.9 to 5.1
|
2.6 months
Interval 1.6 to 2.8
|
2.9 months
Interval 1.1 to 6.8
|
2.6 months
Interval 1.6 to 2.8
|
3.7 months
Interval 1.7 to 5.5
|
2.2 months
Interval 1.4 to 3.0
|
SECONDARY outcome
Timeframe: From randomization to first documented objective response, up to 36 months postdosePopulation: Objective response rate (ORR) and best overall response (BOR) were assessed in the Response Evaluable Set.
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) are reported.
Outcome measures
| Measure |
DS-8201a
n=119 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=51 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=5 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=56 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=19 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=21 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019)
|
60 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
|
56 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
|
42 Participants
|
27 Participants
|
1 Participants
|
28 Participants
|
7 Participants
|
8 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
|
42 Participants
|
27 Participants
|
1 Participants
|
28 Participants
|
7 Participants
|
8 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
|
15 Participants
|
15 Participants
|
2 Participants
|
17 Participants
|
2 Participants
|
8 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019)
|
49 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
|
53 Participants
|
28 Participants
|
1 Participants
|
29 Participants
|
9 Participants
|
10 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
|
51 Participants
|
28 Participants
|
1 Participants
|
29 Participants
|
9 Participants
|
10 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
|
15 Participants
|
16 Participants
|
2 Participants
|
18 Participants
|
2 Participants
|
8 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
|
15 Participants
|
16 Participants
|
2 Participants
|
18 Participants
|
2 Participants
|
8 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020)
|
60 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
|
56 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
|
15 Participants
|
15 Participants
|
2 Participants
|
17 Participants
|
2 Participants
|
8 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020)
|
51 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
|
46 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
|
Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)
Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
|
47 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
Outcome measures
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=20 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=24 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Cmax: Total Anti-HER2 antibody, Cycle 1
|
116 ug/mL
Standard Deviation 30.6
|
105 ug/mL
Standard Deviation 26.1
|
110 ug/mL
Standard Deviation 19.6
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Cmax: Total Anti-HER2 antibody, Cycle 3
|
121 ug/mL
Standard Deviation 28.4
|
115 ug/mL
Standard Deviation 24.2
|
112 ug/mL
Standard Deviation 21.9
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Cmax: DS-8201a, Cycle 1
|
127 ug/mL
Standard Deviation 28.4
|
119 ug/mL
Standard Deviation 29.1
|
127 ug/mL
Standard Deviation 24.5
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Cmax: DS-8201a, Cycle 3
|
137 ug/mL
Standard Deviation 31.1
|
128 ug/mL
Standard Deviation 25.6
|
123 ug/mL
Standard Deviation 23.2
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Ctrough: DS-8201a, Cycle 1
|
5.56 ug/mL
Standard Deviation 3.08
|
4.52 ug/mL
Standard Deviation 2.42
|
9.51 ug/mL
Standard Deviation 23.4
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Ctrough: DS-8201a, Cycle 3
|
13.4 ug/mL
Standard Deviation 17.3
|
8.84 ug/mL
Standard Deviation 3.09
|
13.2 ug/mL
Standard Deviation 18.6
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Ctrough: Total Anti-HER2 antibody, Cycle 1
|
8.56 ug/mL
Standard Deviation 8.60
|
5.33 ug/mL
Standard Deviation 2.97
|
10.0 ug/mL
Standard Deviation 20.5
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
Ctrough: Total Anti-HER2 antibody, Cycle 3
|
15.6 ug/mL
Standard Deviation 13.6
|
12.2 ug/mL
Standard Deviation 5.76
|
14.6 ug/mL
Standard Deviation 17.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Outcome measures
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=20 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=24 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a
Cmax: MAAA-1181a, Cycle 1
|
12.1 ng/mL
Standard Deviation 4.79
|
13.3 ng/mL
Standard Deviation 8.52
|
13.3 ng/mL
Standard Deviation 7.37
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a
Cmax: MAAA-1181a, Cycle 3
|
9.08 ng/mL
Standard Deviation 3.81
|
7.62 ng/mL
Standard Deviation 1.86
|
9.83 ng/mL
Standard Deviation 3.75
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a
Ctrough: MAAA-1181a, Cycle 1
|
0.316 ng/mL
Standard Deviation 0.294
|
0.290 ng/mL
Standard Deviation 0.237
|
0.772 ng/mL
Standard Deviation 2.28
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a
Ctrough: MAAA-1181a Cycle 3
|
0.714 ng/mL
Standard Deviation 2.19
|
0.378 ng/mL
Standard Deviation 0.138
|
1.10 ng/mL
Standard Deviation 1.95
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. No patient samples were collected or analyzed for AUClast DS-8201a and total anti-HER2 antibody for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.
Outcome measures
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=20 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=24 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
AUClast: DS-8201a, Cycle 1
|
611 ug*d/mL
Standard Deviation 150
|
572 ug*d/mL
Standard Deviation 143
|
545 ug*d/mL
Standard Deviation 160
|
—
|
—
|
—
|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
AUC21d: DS-8201a, Cycle 3
|
867 ug*d/mL
Standard Deviation 213
|
746 ug*d/mL
Standard Deviation 197
|
724 ug*d/mL
Standard Deviation 71.9
|
—
|
—
|
—
|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
AUClast: Total Anti-HER2 antibody, Cycle 1
|
667 ug*d/mL
Standard Deviation 241
|
570 ug*d/mL
Standard Deviation 126
|
547 ug*d/mL
Standard Deviation 167
|
—
|
—
|
—
|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
AUC21d: DS-8201a, Cycle 1
|
612 ug*d/mL
Standard Deviation 150
|
572 ug*d/mL
Standard Deviation 143
|
569 ug*d/mL
Standard Deviation 114
|
—
|
—
|
—
|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
AUC21d: Total Anti-HER2 antibody, Cycle 1
|
651 ug*d/mL
Standard Deviation 210
|
570 ug*d/mL
Standard Deviation 126
|
582 ug*d/mL
Standard Deviation 104
|
—
|
—
|
—
|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a
AUC21d: Total Anti-HER2 antibody, Cycle 3
|
888 ug*d/mL
Standard Deviation 244
|
775 ug*d/mL
Standard Deviation 210
|
737 ug*d/mL
Standard Deviation 110
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. No patient samples were collected or analyzed for MAAA-1181a for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Outcome measures
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=20 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=24 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a
AUC21d: MAAA-1181a, Cycle 1
|
46.4 ng*d/mL
Standard Deviation 16.1
|
44.9 ng*d/mL
Standard Deviation 20.1
|
44.5 ng*d/mL
Standard Deviation 22.5
|
—
|
—
|
—
|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a
AUC21d: MAAA-1181a, Cycle 3
|
42.0 ng*d/mL
Standard Deviation 15.1
|
39.4 ng*d/mL
Standard Deviation 8.36
|
44.6 ng*d/mL
Standard Deviation 17.8
|
—
|
—
|
—
|
|
Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a
AUClast: MAAA-1181a, Cycle 1
|
46.7 ng*d/mL
Standard Deviation 16.3
|
53.4 ng*d/mL
Standard Deviation 42.7
|
44.5 ng*d/mL
Standard Deviation 22.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The time to maximum serum concentration (Tmax) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Outcome measures
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=20 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=24 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
DS-8201a, Cycle 3
|
4.00 hours
Interval 0.58 to 7.25
|
4.00 hours
Interval 0.58 to 6.82
|
4.00 hours
Interval 0.68 to 7.02
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
DS-8201a, Cycle 1
|
3.93 hours
Interval 0.0 to 7.15
|
3.90 hours
Interval 1.58 to 7.12
|
3.89 hours
Interval 1.53 to 7.08
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Total Anti-HER2 antibody, Cycle 1
|
3.83 hours
Interval 0.0 to 7.15
|
3.83 hours
Interval 1.58 to 7.08
|
3.87 hours
Interval 1.53 to 7.08
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Total Anti-HER2 antibody, Cycle 3
|
3.98 hours
Interval 0.53 to 7.17
|
4.00 hours
Interval 0.57 to 6.83
|
3.75 hours
Interval 0.53 to 7.03
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
MAAA-1181a, Cycle 1
|
6.85 hours
Interval 3.75 to 7.25
|
6.83 hours
Interval 3.83 to 141.73
|
6.81 hours
Interval 3.83 to 7.08
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
MAAA-1181a, Cycle 3
|
6.80 hours
Interval 3.78 to 7.25
|
6.82 hours
Interval 3.88 to 7.1
|
6.77 hours
Interval 3.98 to 7.07
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in patients with available data in the Pharmacokinetic Analysis Set.
Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.
Outcome measures
| Measure |
DS-8201a
n=124 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=20 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=23 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
MAAA-1181a, Cycle 1
|
5.50 days
Standard Deviation 1.11
|
5.21 days
Standard Deviation 0.939
|
5.61 days
Standard Deviation 1.19
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
MAAA-1181a, Cycle 3
|
7.01 days
Standard Deviation 1.65
|
6.18 days
Standard Deviation 1.02
|
5.80 days
Standard Deviation 1.10
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
DS-8201a, Cycle 1
|
5.77 days
Standard Deviation 1.37
|
5.54 days
Standard Deviation 1.08
|
5.52 days
Standard Deviation 1.17
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
DS-8201a, Cycle 3
|
7.46 days
Standard Deviation 1.82
|
6.40 days
Standard Deviation 1.00
|
6.35 days
Standard Deviation 1.73
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Total Anti-HER2 antibody, Cycle 1
|
6.20 days
Standard Deviation 2.22
|
5.54 days
Standard Deviation 1.01
|
5.65 days
Standard Deviation 1.51
|
—
|
—
|
—
|
|
Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a
Total Anti-HER2 antibody, Cycle 3
|
8.00 days
Standard Deviation 2.04
|
7.90 days
Standard Deviation 2.10
|
6.17 days
Standard Deviation 1.15
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 47 days after last dose, up to 36 months postdosePopulation: Adverse events were assessed in the Safety Analysis Set.
A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
Outcome measures
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=20 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=24 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Any TEAE, 25 months (DCO: Nov 8, 2019)
|
125 Participants
|
54 Participants
|
7 Participants
|
61 Participants
|
20 Participants
|
24 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Any TEAE, 36 months (DCO: Dec 11, 2020)
|
125 Participants
|
54 Participants
|
7 Participants
|
61 Participants
|
20 Participants
|
24 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related TEAEs, 25 months (DCO: Nov 8, 2019)
|
122 Participants
|
51 Participants
|
5 Participants
|
56 Participants
|
19 Participants
|
24 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Serious TEAEs, 25 months (DCO: Nov 8, 2019)
|
55 Participants
|
14 Participants
|
1 Participants
|
15 Participants
|
6 Participants
|
11 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Serious TEAEs, 36 months (DCO: Dec 11, 2020)
|
58 Participants
|
15 Participants
|
1 Participants
|
16 Participants
|
6 Participants
|
11 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019)
|
27 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020)
|
31 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019)
|
19 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020)
|
23 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019)
|
12 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020)
|
15 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019)
|
40 Participants
|
21 Participants
|
0 Participants
|
21 Participants
|
6 Participants
|
8 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020)
|
40 Participants
|
21 Participants
|
0 Participants
|
21 Participants
|
6 Participants
|
8 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020)
|
38 Participants
|
21 Participants
|
0 Participants
|
21 Participants
|
6 Participants
|
7 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019)
|
78 Participants
|
20 Participants
|
3 Participants
|
23 Participants
|
8 Participants
|
10 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020)
|
79 Participants
|
20 Participants
|
3 Participants
|
23 Participants
|
8 Participants
|
10 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019)
|
64 Participants
|
17 Participants
|
2 Participants
|
19 Participants
|
7 Participants
|
10 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
TEAEs associated with death, 25 months (DCO: Nov 8, 2019)
|
8 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
TEAEs associated with death, 36 months (DCO: Dec 11, 2020)
|
9 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related TEAEs, 36 months (DCO: Dec 11, 2020)
|
122 Participants
|
51 Participants
|
5 Participants
|
56 Participants
|
19 Participants
|
24 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019)
|
38 Participants
|
21 Participants
|
0 Participants
|
21 Participants
|
6 Participants
|
7 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020)
|
65 Participants
|
17 Participants
|
2 Participants
|
19 Participants
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 47 days after last dose, up to 36 months postdosePopulation: Adverse events were assessed in the Safety Analysis Set.
A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Outcome measures
| Measure |
DS-8201a
n=125 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 Participants
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=20 Participants
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=24 Participants
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019)
|
18 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020)
|
18 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Malaise, 25 months (DCO: Nov 8, 2019)
|
43 Participants
|
9 Participants
|
1 Participants
|
10 Participants
|
4 Participants
|
9 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Any TEAE, 25 months (DCO: Nov 8, 2019)
|
125 Participants
|
54 Participants
|
7 Participants
|
61 Participants
|
20 Participants
|
24 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Neutrophil count decreased, 36 months (DCO: Dec 11, 2020)
|
79 Participants
|
18 Participants
|
3 Participants
|
21 Participants
|
8 Participants
|
12 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
White blood cell count decreased, 25 months (DCO: Nov 8, 2019)
|
47 Participants
|
18 Participants
|
3 Participants
|
21 Participants
|
4 Participants
|
7 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
White blood cell count decreased, 36 months (DCO: Dec 11, 2020)
|
49 Participants
|
18 Participants
|
3 Participants
|
21 Participants
|
4 Participants
|
7 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019)
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Vomiting, 36 months (DCO: Dec 11, 2020)
|
33 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Constipation, 25 months (DCO: Nov 8, 2019)
|
30 Participants
|
13 Participants
|
1 Participants
|
14 Participants
|
5 Participants
|
5 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Constipation, 36 months (DCO: Dec 11, 2020)
|
31 Participants
|
13 Participants
|
2 Participants
|
15 Participants
|
5 Participants
|
5 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Pyrexia, 25 months (DCO: Nov 8, 2019)
|
30 Participants
|
8 Participants
|
2 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Pyrexia, 36 months (DCO: Dec 11, 2020)
|
31 Participants
|
8 Participants
|
2 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Fatigue, 25 months (DCO: Nov 8, 2019)
|
27 Participants
|
15 Participants
|
0 Participants
|
15 Participants
|
5 Participants
|
6 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Fatigue, 36 months (DCO: Dec 11, 2020)
|
27 Participants
|
15 Participants
|
0 Participants
|
15 Participants
|
5 Participants
|
6 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Alopecia, 25 months (DCO: Nov 8, 2019)
|
28 Participants
|
8 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
1 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Alopecia, 36 months (DCO: Dec 11, 2020)
|
28 Participants
|
8 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
1 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Lymphocyte count decreased, 25 months (DCO: Nov 8, 2019)
|
27 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020)
|
30 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Weight decreased, 25 months (DCO: Nov 8, 2019)
|
17 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Weight decreased, 36 months (DCO: Dec 11, 2020)
|
19 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Oedema peripheral, 25 months (DCO: Nov 8, 2019)
|
13 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Oedema peripheral, 36 months (DCO: Dec 11, 2020)
|
15 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Dysgeusia, 25 months (DCO: Nov 8, 2019)
|
9 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Dysgeusia, 36 months (DCO: Dec 11, 2020)
|
9 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020)
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Any TEAE, 36 months (DCO: Dec 11, 2020)
|
125 Participants
|
54 Participants
|
7 Participants
|
61 Participants
|
20 Participants
|
24 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Nausea, 25 months (DCO: Nov 8, 2019)
|
79 Participants
|
27 Participants
|
2 Participants
|
29 Participants
|
11 Participants
|
19 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Nausea, 36 months (DCO: Dec 11, 2020)
|
79 Participants
|
27 Participants
|
2 Participants
|
29 Participants
|
11 Participants
|
19 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Decreased appetite, 25 months (DCO: Nov 8, 2019)
|
75 Participants
|
27 Participants
|
1 Participants
|
28 Participants
|
13 Participants
|
18 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Decreased appetite, 36 months (DCO: Dec 11, 2020)
|
76 Participants
|
27 Participants
|
1 Participants
|
28 Participants
|
13 Participants
|
18 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Neutrophil count decreased, 25 months (DCO: Nov 8, 2019)
|
77 Participants
|
18 Participants
|
3 Participants
|
21 Participants
|
8 Participants
|
12 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Anaemia, 25 months (DCO: Nov 8, 2019)
|
71 Participants
|
17 Participants
|
2 Participants
|
19 Participants
|
10 Participants
|
10 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Anaemia, 36 months (DCO: Dec 11, 2020)
|
71 Participants
|
17 Participants
|
2 Participants
|
19 Participants
|
10 Participants
|
11 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Platelet count decreased, 25 months (DCO: Nov 8, 2019)
|
47 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Platelet count decreased, 36 months (DCO: Dec 11, 2020)
|
48 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Malaise, 36 months (DCO: Dec 11, 2020)
|
44 Participants
|
9 Participants
|
1 Participants
|
10 Participants
|
4 Participants
|
9 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Diarrhoea, 25 months (DCO: Nov 8, 2019)
|
40 Participants
|
20 Participants
|
0 Participants
|
20 Participants
|
6 Participants
|
8 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Diarrhoea, 36 months (DCO: Dec 11, 2020)
|
41 Participants
|
20 Participants
|
0 Participants
|
20 Participants
|
6 Participants
|
8 Participants
|
|
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Vomiting, 25 months (DCO: Nov 8, 2019)
|
33 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
Adverse Events
DS-8201a
Serious events: 58 serious events
Other events: 125 other events
Deaths: 98 deaths
Physician's Choice Irinotecan
Serious events: 15 serious events
Other events: 54 other events
Deaths: 46 deaths
Physician's Choice Paclitaxel
Serious events: 1 serious events
Other events: 7 other events
Deaths: 4 deaths
Physician's Choice Overall
Serious events: 16 serious events
Other events: 61 other events
Deaths: 50 deaths
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Serious events: 6 serious events
Other events: 20 other events
Deaths: 16 deaths
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Serious events: 11 serious events
Other events: 24 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
DS-8201a
n=125 participants at risk
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 participants at risk
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 participants at risk
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 participants at risk
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=20 participants at risk
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=24 participants at risk
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Sepsis
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Lung infection
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Bacteraemia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Biliary sepsis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Biliary tract infection
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Device-related infection
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Cholangitis infective
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericarditis malignant
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
4/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.4%
13/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
16.7%
4/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
4/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Hemiplegia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Presyncope
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Vascular disorders
Hypotension
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
5/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Gastric stenosis
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Anal stenosis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Nausea
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Cholangitis
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Liver injury
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Disease progression
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Pyrexia
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Fatigue
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Asthenia
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Condition aggravated
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
General physical health deterioration
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Platelet count decreased
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Eye disorders
Cataract
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Eye disorders
Glaucoma
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
Other adverse events
| Measure |
DS-8201a
n=125 participants at risk
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
|
Physician's Choice Irinotecan
n=55 participants at risk
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Paclitaxel
n=7 participants at risk
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Physician's Choice Overall
n=62 participants at risk
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
|
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
n=20 participants at risk
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
|
Exploratory: Naïve HER2 IHC 1+, DS-8201a
n=24 participants at risk
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
63.2%
79/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
49.1%
27/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
28.6%
2/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
46.8%
29/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
55.0%
11/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
79.2%
19/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
11/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
7.3%
4/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.1%
5/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Pneumonia
|
5.6%
7/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
6/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Lung infection
|
4.8%
6/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Influenza
|
3.2%
4/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Pneumonia bacterial
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Conjunctivitis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Folliculitis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Infections and infestations
Sinusitis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
4.8%
6/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
56.8%
71/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
30.9%
17/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
28.6%
2/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
30.6%
19/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
50.0%
10/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
45.8%
11/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.8%
6/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
60.8%
76/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
49.1%
27/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
45.2%
28/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
65.0%
13/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
75.0%
18/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.4%
18/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
12.7%
7/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
12.9%
8/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
20.8%
5/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.8%
11/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
7.3%
4/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
6.5%
4/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
16.7%
4/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.4%
8/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
6.5%
4/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Psychiatric disorders
Insomnia
|
8.8%
11/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
7.3%
4/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.1%
5/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Psychiatric disorders
Delirium
|
3.2%
4/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Dysgeusia
|
7.2%
9/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
7.3%
4/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
6.5%
4/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
20.0%
4/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Dizziness
|
4.0%
5/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Headache
|
3.2%
4/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
7.3%
4/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
6.5%
4/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.2%
4/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
28.6%
2/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Cholinergic syndrome
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Eye disorders
Keratitis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Vascular disorders
Embolism
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
12.5%
3/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.8%
6/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.9%
6/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
9.7%
6/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.8%
11/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.8%
41/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
36.4%
20/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
32.3%
20/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
30.0%
6/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
33.3%
8/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Constipation
|
24.8%
31/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
23.6%
13/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
28.6%
2/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
24.2%
15/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
25.0%
5/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
20.8%
5/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Vomiting
|
26.4%
33/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
9.1%
5/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.1%
5/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
20.0%
4/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
29.2%
7/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.2%
14/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.5%
8/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
12.9%
8/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Stomatitis
|
11.2%
14/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Ascites
|
6.4%
8/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
15.0%
3/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
12.5%
3/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
4/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
4/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
5/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
8.0%
10/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
4.0%
5/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.4%
28/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.5%
8/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.5%
9/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
15.0%
3/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
10/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
6/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.2%
9/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
10/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Malaise
|
35.2%
44/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
16.4%
9/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
16.1%
10/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
20.0%
4/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
37.5%
9/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Fatigue
|
21.6%
27/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
27.3%
15/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
24.2%
15/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
25.0%
5/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
25.0%
6/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Pyrexia
|
24.8%
31/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.5%
8/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
28.6%
2/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
16.1%
10/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
15.0%
3/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
25.0%
6/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Oedema peripheral
|
12.0%
15/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
20.0%
4/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Disease progression
|
2.4%
3/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Asthenia
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.3%
2/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Influenza-like illness
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
General disorders
Injection site extravasation
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Neutrophil count decreased
|
63.2%
79/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
32.7%
18/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
42.9%
3/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
33.9%
21/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
40.0%
8/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
50.0%
12/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
White blood cell count decreased
|
39.2%
49/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
32.7%
18/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
42.9%
3/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
33.9%
21/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
20.0%
4/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
29.2%
7/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Platelet count decreased
|
38.4%
48/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
7.3%
4/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
6.5%
4/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
15.0%
3/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
29.2%
7/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Lymphocyte count decreased
|
24.0%
30/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.6%
2/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
12.5%
3/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Weight decreased
|
15.2%
19/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
9.1%
5/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
8.1%
5/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
20.0%
4/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
29.2%
7/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Aspartate aminotransferase increased
|
9.6%
12/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.8%
11/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.8%
1/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
3.2%
2/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
16.7%
4/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Alanine aminotransferase increased
|
7.2%
9/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.5%
3/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.8%
3/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Blood bilirubin increased
|
8.0%
10/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Blood creatinine increased
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.9%
6/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
9.7%
6/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
10.0%
2/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Urine output decreased
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
6.4%
8/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
4.2%
1/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Gastrointestinal disorders
Periodontal disease
|
1.6%
2/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.80%
1/125 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/55 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
14.3%
1/7 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
1.6%
1/62 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
5.0%
1/20 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
0.00%
0/24 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place