Trial Outcomes & Findings for An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT01868893)
NCT ID: NCT01868893
Last Updated: 2017-04-17
Results Overview
Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Cycles 1 to 6 (28-day cycles)
Results posted on
2017-04-17
Participant Flow
A total of 20 participants were enrolled at 7 study sites in the United States (U.S) between 21 August 2013 and 22 January 2014.
Of 20 participants, one patient withdrew from the study due to neutropenia and did not receive any study drug.
Participant milestones
| Measure |
Obinutuzumab + Chlorambucil
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
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|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Obinutuzumab + Chlorambucil
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
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|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Commercial availability of study drug
|
17
|
|
Overall Study
Neutropenia
|
1
|
Baseline Characteristics
An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Obinutuzumab + Chlorambucil
n=19 Participants
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
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|---|---|
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Age, Continuous
|
67.5 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycles 1 to 6 (28-day cycles)Population: Intent-to-Treat population: It included all enrolled participants in the study.
Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
Outcome measures
| Measure |
Obinutuzumab
n=20 Participants
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6.
|
Chlorambucil
n=20 Participants
Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6.
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|---|---|---|
|
Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study
|
19 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Up to 28 days after the last dose of study drug (up to 7 months from Day 1)Population: Safety Population: It included all enrolled participants who received at least one dose of study drug.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Outcome measures
| Measure |
Obinutuzumab
n=19 Participants
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6.
|
Chlorambucil
Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6.
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|---|---|---|
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Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
Death
|
0 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
Any AEs
|
19 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
Any AEs of Grade 3 and more severity
|
10 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
AEs leading to obinutuzumab discont. or delay
|
8 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
AESI
|
1 participants
|
—
|
|
Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death
Any SAEs
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)Population: Efficacy evaluable population: It included participants who received at least one dose of study drug and had measurable disease at baseline and at least one post-baseline tumor assessment or who died within 28 days after the last dose of the study drug
Objective response is defined as either complete response \[CR\], complete response with incomplete recovery \[CRi\], or partial response \[PR\] as determined by the treating physician's standard practice at the end of treatment or premature discontinuation from study per the International Workshop on Chronic Lymphocytic Leukemia Criteria (iwCLL criteria). Patients who have not achieved a CR or a PR, and who have not exhibited progressive disease, will be considered to have stable disease (which is equivalent to a nonresponse).
Outcome measures
| Measure |
Obinutuzumab
n=6 Participants
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6.
|
Chlorambucil
Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6.
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|---|---|---|
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Number of Participants With Objective Response
|
4 participants
|
—
|
Adverse Events
Obinutuzumab + Chlorambucil
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Obinutuzumab + Chlorambucil
n=19 participants at risk
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
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|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eesophageal ulcers
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Obinutuzumab + Chlorambucil
n=19 participants at risk
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
31.6%
6/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
26.3%
5/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.3%
5/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
26.3%
5/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
4/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
63.2%
12/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
36.8%
7/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
26.3%
5/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
15.8%
3/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
21.1%
4/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
31.6%
6/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Bladder pain
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.1%
4/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.5%
2/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
21.1%
4/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Embolism
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Up to 28 days after the last dose of study drug (up to 7 months from Day 1)
SAEs and other AEs were collected in the safety population, which was defined as all enrolled participants who received at least one dose of study drug.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER