TriangleNCT00543543 · STUDY IN CONTEXT
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.
HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- trial label
- Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 6
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0003
- source section id
- NCT00543543-om-0003
- source outcome index
- 3
- endpoint
- Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
- endpoint definition
- Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.
- time origin
- Month 60: predose 4 in the Extension Study (Cohort 1)
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0000
- source section id
- NCT00543543-om-0000
- source outcome index
- 0
- endpoint
- Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)
- endpoint definition
- HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
- time origin
- From Day 1 until >=30 cases accumulate, up to Month 54 in the base study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0001
- source section id
- NCT00543543-om-0001
- source outcome index
- 1
- endpoint
- Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)
- endpoint definition
- HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
- time origin
- Up to Month 54 in the base study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0002
- source section id
- NCT00543543-om-0002
- source outcome index
- 2
- endpoint
- Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
- endpoint definition
- Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.
- time origin
- 4 weeks postdose 3 in the base study
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0004
- source section id
- NCT00543543-om-0004
- source outcome index
- 4
- endpoint
- Base Study: Percentage of Participants With One or More Adverse Event
- endpoint definition
- An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
- time origin
- Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population included all participants who received \>=1 vaccination and had safety follow-up
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0005
- source section id
- NCT00543543-om-0005
- source outcome index
- 5
- endpoint
- Base Study: Percentage of Participants With One or More Injection-site Adverse Event
- endpoint definition
- An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
- time origin
- Up to Day 5 after any vaccination
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population included all participants who received \>=1 vaccination and had safety follow-up
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Mid-dose V503
- regimen
- V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
- analyzed count
- 6016
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Gardasil
- regimen
- Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
- analyzed count
- 6017
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Mid-dose V503
- regimen
- V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
- analyzed count
- 6016
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Gardasil
- regimen
- Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
- analyzed count
- 6017
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Mid-dose V503
- regimen
- V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
- analyzed count
- 6792
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Gardasil
- regimen
- Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
- analyzed count
- 6795
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Extension Study: Mid-dose V503 (Cohort 1)
- regimen
- V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
- analyzed count
- 150
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Low-dose V503
- regimen
- V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
- analyzed count
- 310
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Mid-dose V503
- regimen
- V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
- analyzed count
- 7071
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0004
- arm key
- OG002
- arm label
- High-dose V503
- regimen
- V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
- analyzed count
- 305
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0004#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0004
- arm key
- OG003
- arm label
- Gardasil
- regimen
- Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
- analyzed count
- 7078
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0004#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Low-dose V503
- regimen
- V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
- analyzed count
- 310
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00543543-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- harm key
- EG000
- source section id
- NCT00543543-ae
- event group key
- EG000
- event group label
- Base Study: Low-Dose V503
- serious affected
- 4
- serious at risk
- 310
- other affected
- 278
- other at risk
- 310
- frequency threshold
- 5
- collection period
- Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
- event definition
- The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- harm key
- EG001
- source section id
- NCT00543543-ae
- event group key
- EG001
- event group label
- Base Study: Mid-dose V503
- serious affected
- 233
- serious at risk
- 7071
- other affected
- 6551
- other at risk
- 7071
- frequency threshold
- 5
- collection period
- Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
- event definition
- The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- harm key
- EG002
- source section id
- NCT00543543-ae
- event group key
- EG002
- event group label
- Base Study: High-dose V503
- serious affected
- 5
- serious at risk
- 305
- other affected
- 280
- other at risk
- 305
- frequency threshold
- 5
- collection period
- Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
- event definition
- The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- harm key
- EG003
- source section id
- NCT00543543-ae
- event group key
- EG003
- event group label
- Base Study: Gardasil
- serious affected
- 184
- serious at risk
- 7078
- other affected
- 6268
- other at risk
- 7078
- frequency threshold
- 5
- collection period
- Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
- event definition
- The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- harm key
- EG004
- source section id
- NCT00543543-ae
- event group key
- EG004
- event group label
- Extension Study: Mid-dose V503 (Cohort 1)
- serious affected
- 1
- serious at risk
- 150
- other affected
- 130
- other at risk
- 150
- frequency threshold
- 5
- collection period
- Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
- event definition
- The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-condyloma-acuminatum
- nct id
- NCT00543543
- harm key
- EG005
- source section id
- NCT00543543-ae
- event group key
- EG005
- event group label
- Extension Study: Mid-dose V503 (Cohort 2)
- serious affected
- 25
- serious at risk
- 3049
- other affected
- 89
- other at risk
- 3049
- frequency threshold
- 5
- collection period
- Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
- event definition
- The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice