Trial Outcomes & Findings for Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) (NCT NCT00954512)
NCT ID: NCT00954512
Last Updated: 2018-08-24
Results Overview
Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
Results posted on
2018-08-24
Participant Flow
Participant milestones
| Measure |
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab
Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-FU 400 mg/m\^2 bolus followed by 2400 mg/m\^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 IV followed by once-weekly doses of 250 mg/m\^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
|
Regimen B: Carboplatin + Paclitaxel + Robatumumab
Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m\^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab
Participants with gastric adenocarcinoma receive epirubicin 50 mg/m\^2 IV PLUS cisplatin 60 mg/m\^2 IV PLUS 5-FU 200 mg/m\^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen D: Trastuzumab + Robatumumab
Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab
Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m\^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
0
|
2
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
0
|
2
|
4
|
4
|
Reasons for withdrawal
| Measure |
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab
Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-FU 400 mg/m\^2 bolus followed by 2400 mg/m\^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 IV followed by once-weekly doses of 250 mg/m\^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
|
Regimen B: Carboplatin + Paclitaxel + Robatumumab
Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m\^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab
Participants with gastric adenocarcinoma receive epirubicin 50 mg/m\^2 IV PLUS cisplatin 60 mg/m\^2 IV PLUS 5-FU 200 mg/m\^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen D: Trastuzumab + Robatumumab
Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab
Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m\^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Symptomatic Deterioration
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Progression of Disease
|
2
|
1
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
Baseline characteristics by cohort
| Measure |
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab
n=2 Participants
Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-FU 400 mg/m\^2 bolus followed by 2400 mg/m\^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 IV followed by once-weekly doses of 250 mg/m\^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
|
Regimen B: Carboplatin + Paclitaxel + Robatumumab
n=3 Participants
Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m\^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab
Participants with gastric adenocarcinoma receive epirubicin 50 mg/m\^2 IV PLUS cisplatin 60 mg/m\^2 IV PLUS 5-FU 200 mg/m\^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen D: Trastuzumab + Robatumumab
n=2 Participants
Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
n=4 Participants
Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab
n=4 Participants
Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m\^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.0 Years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
54.0 Years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
—
|
48.0 Years
STANDARD_DEVIATION 2.8 • n=4 Participants
|
53.3 Years
STANDARD_DEVIATION 13.5 • n=21 Participants
|
70.8 Years
STANDARD_DEVIATION 3.0 • n=10 Participants
|
56.5 Years
STANDARD_DEVIATION 11.4 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)Population: The All Treated Set (efficacy) consisted of all participants who received ≥1 dose of study drug and were evaluable for this outcome measure.
Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD).
Outcome measures
| Measure |
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab
n=2 Participants
Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-FU 400 mg/m\^2 bolus followed by 2400 mg/m\^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 IV followed by once-weekly doses of 250 mg/m\^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
|
Regimen B: Carboplatin + Paclitaxel + Robatumumab
n=3 Participants
Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m\^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab
Participants with gastric adenocarcinoma receive epirubicin 50 mg/m\^2 IV PLUS cisplatin 60 mg/m\^2 IV PLUS 5-FU 200 mg/m\^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen D: Trastuzumab + Robatumumab
n=2 Participants
Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
n=3 Participants
Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab
n=2 Participants
Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m\^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
Complete Response (CR)
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
Partial Response (PR)
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
Stable Disease (SD)
|
0 Participants
|
2 Participants
|
—
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
Progressive Disease (PD)
|
2 Participants
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
Not Assessable (NA)
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
Incomplete Response/Stable Disease (IR/SD)
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)Population: The All Treated Set (safety) consisted of all participants who received ≥1 dose of study drug.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.
Outcome measures
| Measure |
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab
n=2 Participants
Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-FU 400 mg/m\^2 bolus followed by 2400 mg/m\^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 IV followed by once-weekly doses of 250 mg/m\^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
|
Regimen B: Carboplatin + Paclitaxel + Robatumumab
n=3 Participants
Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m\^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab
Participants with gastric adenocarcinoma receive epirubicin 50 mg/m\^2 IV PLUS cisplatin 60 mg/m\^2 IV PLUS 5-FU 200 mg/m\^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen D: Trastuzumab + Robatumumab
n=2 Participants
Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
n=4 Participants
Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab
n=4 Participants
Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m\^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)
|
2 Participants
|
3 Participants
|
—
|
2 Participants
|
4 Participants
|
4 Participants
|
Adverse Events
Regimen A: FOLFIRI (+/- Cetuximab) + Robatumumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Regimen B: Carboplatin + Paclitaxel + Robatumumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Regimen D: Trastuzumab + Robatumumab
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Regimen F: Gemcitabine (+/- Erlotinib) + Robatumumab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen A: FOLFIRI (+/- Cetuximab) + Robatumumab
n=2 participants at risk
Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-FU 400 mg/m\^2 bolus followed by 2400 mg/m\^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 followed by once-weekly doses of 250 mg/m\^2) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 2 weeks.
|
Regimen B: Carboplatin + Paclitaxel + Robatumumab
n=3 participants at risk
Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m\^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen D: Trastuzumab + Robatumumab
n=2 participants at risk
Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
n=4 participants at risk
Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen F: Gemcitabine (+/- Erlotinib) + Robatumumab
n=4 participants at risk
Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m\^2 on Days 1, 8, 15, 22, 29, 36, and 43 (± erlotinib 100 mg per day) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 8 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
General disorders
PYREXIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
Other adverse events
| Measure |
Regimen A: FOLFIRI (+/- Cetuximab) + Robatumumab
n=2 participants at risk
Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-FU 400 mg/m\^2 bolus followed by 2400 mg/m\^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 followed by once-weekly doses of 250 mg/m\^2) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 2 weeks.
|
Regimen B: Carboplatin + Paclitaxel + Robatumumab
n=3 participants at risk
Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m\^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
|
Regimen D: Trastuzumab + Robatumumab
n=2 participants at risk
Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
n=4 participants at risk
Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
|
Regimen F: Gemcitabine (+/- Erlotinib) + Robatumumab
n=4 participants at risk
Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m\^2 on Days 1, 8, 15, 22, 29, 36, and 43 (± erlotinib 100 mg per day) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 8 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
2/4 • Number of events 10 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 6 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
75.0%
3/4 • Number of events 4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
2/4 • Number of events 11 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
75.0%
3/4 • Number of events 12 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
ANAL INFLAMMATION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
2/4 • Number of events 3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
GINGIVITIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
2/2 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
66.7%
2/3 • Number of events 4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
75.0%
3/4 • Number of events 3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
General disorders
FATIGUE
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
66.7%
2/3 • Number of events 3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
2/4 • Number of events 9 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
75.0%
3/4 • Number of events 5 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
General disorders
PYREXIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
ESCHERICHIA INFECTION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Investigations
TRANSAMINASES INCREASED
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
50.0%
1/2 • Number of events 4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
100.0%
3/3 • Number of events 9 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 6 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERPHAGIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 5 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
100.0%
2/2 • Number of events 3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
66.7%
2/3 • Number of events 9 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
100.0%
2/2 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
2/4 • Number of events 3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
2/4 • Number of events 3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
66.7%
2/3 • Number of events 4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
100.0%
3/3 • Number of events 4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
PHANTOM PAIN
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Psychiatric disorders
ANTICIPATORY ANXIETY
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL BLISTERING
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/3 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
50.0%
1/2 • Number of events 1 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/2 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
0.00%
0/4 • Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
The All Treated Set consisted of all participants who received ≥1 dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
- Publication restrictions are in place
Restriction type: OTHER