Trial Outcomes & Findings for Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease (NCT NCT04432298)
NCT ID: NCT04432298
Last Updated: 2022-07-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Day 28
Results posted on
2022-07-18
Participant Flow
Participant milestones
| Measure |
Pamrevlumab
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
11
|
11
|
|
Overall Study
Safety Population
|
9
|
11
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Pamrevlumab
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Overall Study
Other than specified
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
Baseline characteristics by cohort
| Measure |
Pamrevlumab
n=11 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=11 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 10 • n=5 Participants
|
61 years
STANDARD_DEVIATION 14 • n=7 Participants
|
61 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: ITT Population: All randomized participants.
Outcome measures
| Measure |
Pamrevlumab
n=11 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=11 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: ITT Population: All randomized participants.
Outcome measures
| Measure |
Pamrevlumab
n=11 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=11 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: ITT Population: All randomized participants.
Outcome measures
| Measure |
Pamrevlumab
n=11 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=11 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).
Outcome measures
| Measure |
Pamrevlumab
n=6 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=8 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Time to Recovery as Based on a Modified 8-Point Ordinal Scale
|
11 days
Standard Deviation 10
|
11 days
Standard Deviation 12
|
SECONDARY outcome
Timeframe: up to Day 28Population: ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.
Outcome measures
| Measure |
Pamrevlumab
n=4 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=3 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)
|
16 days
Standard Deviation 14
|
12 days
Standard Deviation 17
|
SECONDARY outcome
Timeframe: up to Day 28Population: ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.
Outcome measures
| Measure |
Pamrevlumab
n=2 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=2 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Days on Mechanical Ventilation and/or ECMO
|
20.5 days
Standard Deviation 0.0
|
8.7 days
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: up to Day 28Population: ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation.
Outcome measures
| Measure |
Pamrevlumab
n=3 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=2 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Time to Mechanical Ventilation/ECMO or All-cause Mortality
|
14 days
Standard Deviation 11
|
14 days
Standard Deviation 1
|
SECONDARY outcome
Timeframe: up to Day 28Population: ITT Population: All randomized participants.
Outcome measures
| Measure |
Pamrevlumab
n=11 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=11 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Number of Participants With All-cause Mortality
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Day 28Population: Due to early termination of the study, data was not collected for the assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Day 28Population: ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation.
Outcome measures
| Measure |
Pamrevlumab
n=2 Participants
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=1 Participants
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Time to Death From Any Cause
|
17 days
Standard Deviation 15
|
13 days
Standard Deviation NA
Not evaluable due to small number of events.
|
SECONDARY outcome
Timeframe: up to Day 28Population: Due to early termination of the study, data was not collected for the assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to Day 28Population: Due to early termination of the study, data was not collected for the assessment.
Outcome measures
Outcome data not reported
Adverse Events
Pamrevlumab
Serious events: 5 serious events
Other events: 4 other events
Deaths: 3 deaths
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pamrevlumab
n=9 participants at risk
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=11 participants at risk
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
22.2%
2/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Vascular disorders
Shock
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Vascular disorders
Peripheral artery thrombosis
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Vascular disorders
Peripheral ischaemia
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
Other adverse events
| Measure |
Pamrevlumab
n=9 participants at risk
Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
Placebo
n=11 participants at risk
Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
22.2%
2/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Endocrine disorders
Adrenal mass
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
General disorders
Oedema
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Infections and infestations
Clostridium difficile infection
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Infections and infestations
Septic shock
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
18.2%
2/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Investigations
Transaminases increased
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Investigations
Blood glucose increased
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
18.2%
2/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
18.2%
2/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
9.1%
1/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
|
Vascular disorders
Peripheral ischaemia
|
11.1%
1/9 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
0.00%
0/11 • Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).
- Publication restrictions are in place
Restriction type: OTHER