Trial Outcomes & Findings for Paclitaxel vs Paclitaxel + Cetuximab in Recurrent - Metastatic Head & Neck Carcinoma After Failure of a 1º Chemotherapy (NCT NCT03887442)
NCT ID: NCT03887442
Last Updated: 2021-01-07
Results Overview
The primary endpoint was to select the most effective treatment arm based on the progression-free survival (PFS) reached in each treatment arm. This was defined as the time elapsed from inclusion in the study until the date when disease progression or death (for any cause) was documented.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The primary endopoint was not analyzed.
Results posted on
2021-01-07
Participant Flow
The study was carried out in 10 academic medical centers in Spain. First patient in was on 16-February-2011 and the study was closed (last patient in) on 02-October-2012.
Participant milestones
| Measure |
Paclitaxel
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
|
Cetuximab + Paclitaxel
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Paclitaxel
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
|
Cetuximab + Paclitaxel
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Paclitaxel vs Paclitaxel + Cetuximab in Recurrent - Metastatic Head & Neck Carcinoma After Failure of a 1º Chemotherapy
Baseline characteristics by cohort
| Measure |
Paclitaxel
n=9 Participants
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
|
Cetuximab + Paclitaxel
n=8 Participants
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.16 years
STANDARD_DEVIATION 7.25 • n=99 Participants
|
58.48 years
STANDARD_DEVIATION 8.76 • n=107 Participants
|
60.96 years
STANDARD_DEVIATION 8.11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The primary endopoint was not analyzed.Population: Only 17 patients out of a planned protocol number of 80 were recruited to the study, owing to premature closure of the study. Two of those patients did not meet some of the inclusion and/or exclusion criteria. Database lock: 3 June 2013. There were insufficient numbers of patients to be able to analyse the efficacy endpoints. The possible discrepancies that were pending resolution have been closed as "Premature closure of the study. Deviation DN13/024". .
The primary endpoint was to select the most effective treatment arm based on the progression-free survival (PFS) reached in each treatment arm. This was defined as the time elapsed from inclusion in the study until the date when disease progression or death (for any cause) was documented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The secondary endopoint was not analyzed.Population: Only 17 patients out of a planned protocol number of 80 were recruited to the study, owing to premature closure of the study (Database lock: 3 June 2013). There were insufficient numbers of patients to be able to analyse the secondary endpoints. The possible discrepancies that were pending resolution have been closed as "Premature closure of the study. Deviation DN13/024".
Calculate overall survival (OS) in both arms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. Neither the primary nor the secondary endopoints were analyzed.Population: Only 17 patients out of a planned protocol number of 80 were recruited to the study, owing to premature closure of the study. Two of those patients did not meet some of the inclusion and/or exclusion criteria. Database lock: 3 June 2013. There were insufficient numbers of patients to be able to analyse the primary and secondary endpoints of the study
Calculate the percentage of objective responses (OR), following the new RECIST criteria, obtained in both arms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The duration of the study (Nineteen months) and until the last patient included completed one year of follow up / died or was lost to FU. Adverse events were registered from study entry until 60 days after receiving the last dose of study drug.Population: This safety analysis includes all 17 patients (Database lock: 3 June 2013). There were insufficient numbers of patients to be able to analyse the efficacy endpoints. The possible discrepancies that were pending resolution have been closed as "Premature closure of the study. Deviation DN13/024".
To perform a descriptive analysis of the adverse events observed in the patients included in the study. Further analysis could not be performed due to early closure of this study due to lack of accrual. Adverse events were registered from study entry until 60 days after receiving the last dose of study drug.
Outcome measures
| Measure |
Paclitaxel
n=9 Participants
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
|
Cetuximab + Paclitaxel
n=8 Participants
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
|
|---|---|---|
|
Participants With Adverse Events
|
9 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Only 17 patients out of a planned protocol number of 80 were recruited to the study, owing to premature closure of the study (Database lock: 3 June 2013). There were insufficient numbers of patients to be able to analyse the primary and secondary endpoints. The possible discrepancies that were pending resolution have been closed as "Premature closure of the study. Deviation DN13/024".
Evaluate treatment compliance rate in both treatment arms, in order to analyze it, the dose intensity would be calculated as the quantity of each of the administered study drugs per unit of time (mg/m2/week) regardless of the treatment arm. To analyze the relative dose intensity, the dose of each administered drug will be divided per a unit of time and the planned quantity of each drug according to the doses described in the protocol.
Outcome measures
Outcome data not reported
Adverse Events
Paclitaxel
Serious events: 4 serious events
Other events: 9 other events
Deaths: 6 deaths
Cetuximab + Paclitaxel
Serious events: 4 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Paclitaxel
n=9 participants at risk
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
|
Cetuximab + Paclitaxel
n=8 participants at risk
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture of humerus
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Pneumococcal pneumonia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Mouth bleeding
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
Other adverse events
| Measure |
Paclitaxel
n=9 participants at risk
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
Paclitaxel: Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
|
Cetuximab + Paclitaxel
n=8 participants at risk
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
Cetuximab + Paclitaxel: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
|
|---|---|---|
|
General disorders
Edema
|
11.1%
1/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
1/9 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
37.5%
3/8 • Number of events 6 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Peripheral neuropathy
|
22.2%
2/9 • Number of events 6 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 4 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Asthenia
|
55.6%
5/9 • Number of events 8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
62.5%
5/8 • Number of events 16 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Post-surgical wound infection
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Ageusia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.4%
4/9 • Number of events 4 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in an extremity
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Naso-pharyngitis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Mucosal inflammation
|
33.3%
3/9 • Number of events 4 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
75.0%
6/8 • Number of events 14 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Pain
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 6 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
3/9 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Hypoesthesia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Paresthesia
|
33.3%
3/9 • Number of events 5 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Dysesthesia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Oral Candidiasis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal pain
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar Erythrodysesthesia Syndrome
|
33.3%
3/9 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Gingivitis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Peripheral edema
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 7 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Xerosis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Ear and labyrinth disorders
Loss of hearing
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Face swelling
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Mouth bleeding
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Bad breath
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Ear and labyrinth disorders
Ear ache
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 4 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Sensory peripheral neuropathy
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Fatigue
|
22.2%
2/9 • Number of events 4 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Metabolism and nutrition disorders
Loss of appetite
|
22.2%
2/9 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Ear and labyrinth disorders
Ear disorder
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Cervicalgia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Eye disorders
Excessive tearing
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Bronchopneumonia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Rectal bleeding
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
0.00%
0/8 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
37.5%
3/8 • Number of events 3 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
25.0%
2/8 • Number of events 6 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal swelling
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Eye disorders
Swollen eyelids
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Mouth pain
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Teeth deterioration
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
General disorders
Decline in general physical status
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Mass in neck
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
37.5%
3/8 • Number of events 4 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 2 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.
|
Additional Information
Carmen Montalbán, Manager
TTCC Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Phone: +34676154172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place