Trial Outcomes & Findings for A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study (NCT NCT00959647)
NCT ID: NCT00959647
Last Updated: 2026-05-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)
Results posted on
2026-05-08
Participant Flow
Participant milestones
| Measure |
Vismodegib 150 mg
Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
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|---|---|
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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19
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Reasons for withdrawal
| Measure |
Vismodegib 150 mg
Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
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|---|---|
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Overall Study
Adverse Event
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2
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Overall Study
Progressive disease
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6
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Overall Study
Study Ended by Sponsor
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4
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Overall Study
Withdrawal by Subject
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7
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Baseline Characteristics
A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
Baseline characteristics by cohort
| Measure |
Vismodegib 150 mg
n=19 Participants
Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
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|---|---|
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Age, Continuous
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57.4 years
STANDARD_DEVIATION 15.4 • n=41 Participants
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Sex: Female, Male
Female
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4 Participants
n=41 Participants
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Sex: Female, Male
Male
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15 Participants
n=41 Participants
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Race/Ethnicity, Customized
White
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19 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)Population: Safety population: All participants who had received at least 1 dose of study medication.
Outcome measures
| Measure |
Vismodegib 150 mg
n=19 Participants
Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
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|---|---|
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Incidence of Participants Who Experienced at Least One Adverse Event
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17 Participants
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PRIMARY outcome
Timeframe: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)Population: Safety population: All participants who had received at least 1 dose of study medication.
Outcome measures
| Measure |
Vismodegib 150 mg
n=19 Participants
Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
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|---|---|
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Incidence of Participants Who Discontinued Treatment Due to an Adverse Event
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2 Participants
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SECONDARY outcome
Timeframe: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days)The investigator used the adverse event (AE) grading (severity) scale found in the NCI CTCAE v3.0 to assess AE severity, with grades ranging from 1 to 5 having the following descriptions: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is very severe, life threatening or disabling, and Grade 5 is death related to AE.
Outcome measures
| Measure |
Vismodegib 150 mg
n=19 Participants
Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
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Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
NCI CTCAE, Any Grade
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17 Participants
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Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
NCI CTCAE Grade 1
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4 Participants
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Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
NCI CTCAE Grade 2
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7 Participants
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Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
NCI CTCAE Grade 3
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6 Participants
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Adverse Events
Vismodegib 150 mg
Serious events: 3 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Vismodegib 150 mg
n=19 participants at risk
Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
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|---|---|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Hepatobiliary disorders
Bile duct obstruction
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Gastrointestinal haemorrhage
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Reproductive system and breast disorders
Tubo-ovarian abscess
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Other adverse events
| Measure |
Vismodegib 150 mg
n=19 participants at risk
Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
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|---|---|
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Gastrointestinal disorders
Diarrhoea
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52.6%
10/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Nausea
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31.6%
6/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Constipation
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26.3%
5/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Flatulence
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15.8%
3/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Vomiting
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15.8%
3/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Gastritis
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10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Abdominal discomfort
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Abdominal pain upper
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Dental caries
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Dyspepsia
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Gastrointestinal haemorrhage
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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Gastrointestinal disorders
Inguinal hernia
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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General disorders
Fatigue
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42.1%
8/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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General disorders
Pyrexia
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10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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General disorders
Asthenia
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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General disorders
Chest pain
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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General disorders
Hernia
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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General disorders
Influenza like illness
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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General disorders
Local swelling
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5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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General disorders
Oedema peripheral
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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|
General disorders
Pain
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
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General disorders
Polyp
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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|
General disorders
Swelling
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
47.4%
9/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.6%
6/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
31.6%
6/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
31.6%
6/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Hepatic enzyme increased
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Blood pressure increased
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Prostatic specific antigen increased
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.8%
3/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.8%
3/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Parkinson's disease
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Parosmia
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
21.1%
4/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
2/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Purulent discharge
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Rash pustular
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Eye disorders
Dry eye
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Eye disorders
Eyelid cyst
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nocturia
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary straining
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Vascular disorders
Hot flush
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
5.3%
1/19 • For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
|
Additional Information
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