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: 2015-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Baseline until 30 days following the last administration of study treatment
Results posted on
2015-01-07
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
|
0
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Overall Study
NOT COMPLETED
|
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
|
6
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Overall Study
Study terminated by sponsor
|
4
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Overall Study
Withdrawal by Subject
|
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
|
57.4 years
STANDARD_DEVIATION 15.4 • n=93 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=93 Participants
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Sex: Female, Male
Male
|
15 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline until 30 days following the last administration of study treatmentPopulation: 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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Percentage of Participants Who Experienced at Least 1 Adverse Event
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89.5 Percentage of participants
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PRIMARY outcome
Timeframe: Baseline until 30 days following the last administration of study treatmentPopulation: 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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Percentage of Participants Who Discontinued Treatment Due to an Adverse Event
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10.5 Percentage of participants
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SECONDARY outcome
Timeframe: 30 days following the last administration of study treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days following the last administration of study treatmentOutcome measures
Outcome data not reported
Adverse Events
Vismodegib 150 mg
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 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
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Tubo-ovarian abscess
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
52.6%
10/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
31.6%
6/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
26.3%
5/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
15.8%
3/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dental caries
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
42.1%
8/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Hernia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Local swelling
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Pain
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Polyp
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
General disorders
Swelling
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.6%
6/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
31.6%
6/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Hepatic enzyme increased
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Blood pressure increased
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Investigations
Prostatic specific antigen increased
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.8%
3/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.8%
3/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
31.6%
6/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Parkinson's disease
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Nervous system disorders
Parosmia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
21.1%
4/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
2/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Purulent discharge
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Rash pustular
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Eye disorders
Dry eye
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Eye disorders
Eyelid cyst
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
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 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nocturia
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary straining
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Vascular disorders
Hot flush
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
Safety population: All participants who had received at least 1 dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
5.3%
1/19 • From Baseline until 30 days following the last administration of study treatment.
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