HOUSEHOLD CHARACTERISTICS ER EROCCUR Has the Malaria Control Program performed Indoor Residual Insecticide Spraying (IRS) of your home in the last 12 months? ERTERM= Indoor residual insecticide spraying; EREVLINT=-P12M Yes No Did you sleep under an insecticide treated bed-net last night? ERTERM=Sleep under an insecticide treated bed-net; EREVINTX=LAST NIGHT Yes No HIV STATUS LB Was HIV status collected for this study? LBYN Yes No HIV status at enrolment LBORRES where LBTESTCD=HIV Positive Negative How was HIV status at enrolment determined? Self-report HIV laboratory test If HIV positive, date of last CD4 count where LBTESTCD= CD4 CD4 abs. LBORRES where LBTESTCD=CD4 and LBORRESU=/uL CD4 % LBORRES LBTESTCD=CD4 and LBORRESU=% If HIV positive, date of last viral load LBDTC where LBTESTCD=RNA and LBCAT=VIRAL LOAD and NHOID=HUMAN IMMUNODEFICIENCY VIRUS Viral load result LBORRES where LBTESTCD =RNA Viral load units LBORRESU where LBTESTCD =RNA |__|__|-|__|__|__|-|__|__|__|__| % |__|__|-|__|__|__|-|__|__|__|__| cells/mm3 UNK UNK UNK
|__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| Yes Mild Moderate Severe |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| Yes Mild Moderate Severe |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| Yes Mild Moderate Severe
VISIT 1 MALARIA DIAGNOSTIC TEST LB Was malaria RDT performed? MBPERFYN NOT SUBMITTED Yes No NA Date MBDAT MBDTC |__|__|-|__|__|__|-|__|__|__|__| Time MBTIM MBDTC |__|__|:|__|__| Test type MBTESTCD/MBTEST Lot number DIVAL when DIPARM=Lot name DIVAL when DIPARM=Trade Name Result MBORRES Not done MBSTAT Reason not done MBREASND Pf Pf+Pan Pan Other If other, specify ______________________ Positive Negative Invalid MICROSCOPY = MALARIA MICROSCOPY REPEAT AS PER PROTOCOL Collection date and time MBDAT MBDTC Reader number MBEVAL, MBEVALID Slide quality SDQUAL Smear type MBMETHOD Parasite type MBTESTCD/ TEST Parasite count MBORRES Parasite count units MBORRESU Malaria species MBTESTCD/TEST |__|__|-|__|__|__|-|__|__|__|__| Good Thick smear Asexual |__|__|__|__| /_____WBC /_____HPF Pf Pv Po Poor Thin smear /_____RBC Pm Pk |__|__|:|__|__| MBTIM MBDTC Missing Thick smear Sexual |__|__|__|__| /_____WBC /_____HPF |__|__|-|__|__|__|-|__|__|__|__| Good Thick smear Asexual /_____WBC /_____HPF Pf Pv Po
|__|.|__||__| |__|__|-|__|__|__|-|__|__|__|__| Yes No Yes No Yes No |__|__|:|__|__| Dose Redose |__|__|:|__|__|
Was a sample for pregnancy testing? LBPREFYN NOT SUBMITTED Yes No NA80 Date and time of sample |__|__|-|__|__|__|-|__|__|__|__| LBDAT LBDTC |__|__|:|__|__| LBTIM LBDTC Pregnancy test name LBTEST Results LBORRES Method LBMETH Not done LBSTAT Reason not done LBREASND
APPENDIX A MOLECULAR GENOTYPING = FOR P. falciparum (NHOID=PLASMODIUM FALCIPARUM) Was molecular genotyping for P. falciparum performed (Y/N) PFPERF NOT SUBMITTED Yes No NA Study day PFDY Date of sample PFDAT PFDTC MSP 1 PFGENRI MSP 2 PFGENRI PFGENRI Other loci specify Not done PFSTAT Reason not done PFREASND Family PFTEST=Allelic family Bp PFTEST= Amplicon size Family PFTEST=Allelic family Bp PFTEST= Amplicon size Bp PFTEST= Amplicon size Marker name PFGENRI Bp PFTEST= Amplicon size Visit1 (Pre-dose) |__|__|-|__|__|__|-|__|__|__|__| K1 KI_PFORRES PFORRES FC27 FC27_PFORRES PFORRES PFORRES PFORRES MAD20 MAD20_PFORRES PFORRES IC/3D7 PFORRES PFORRES RO33 RO33_PFORRES PFORRES PFORRES Day of recurrence |__|__|-|__|__|__|-|__|__|__|__| K1 KI_PFORRES PFORRES FC27 FC27_PFORRES PFORRES MAD20 MAD20_PFORRES PFORRES IC/3D7 PFORRES RO33 RO33_PFORRES PFORRES PFORRES APPENDIX B MOLECULAR GENOTYPING = FOR P. vivax (NHOID=PLASMODIUM VIVAX ), PFGENTYP = MICROSATELLITE
Was molecular genotyping for P. vivax performed (Y/N) PFPERF NOT SUBMITTED Yes No NA Study day PFDY Date of sample PFDAT PFDTC MSP 1 PFGENRI Other surface proteins Microsatellites PFEGNTYP Not done PFSTAT Reason not done PFREASND Domain PFGENSR Bp PFTEST= Amplicon size Marker gene name PFGENRI Bp PFORRES Marker name PFGENRI Bp PFORRES Visit1 (Pre-dose) |__|__|-|__|__|__|-|__|__|__|__| F1 PFORRES PFORRES MS16 PFORRES F3 PFORRES MSP4 PFORRES Pv3.27 PFORRES MSP5 PFORRES Pv1.501 PFORRES Day of recurrence/ relapse |__|__|-|__|__|__|-|__|__|__|__| F1 PFORRES MSP3a PFORRES MS16 PFORRES F3 PFORRES MSP4 PFORRES Pv3.27 PFORRES MSP5 PFORRES Pv1.501 PFORRES APPENDIX C PHARMACOKINETIC (PK) SAMPLING PC Was PK sampling performed? PCYN NOT SUBMITTED Yes No NA Collection date PCDAT PCDTC Collection time PCDTC PCTPT Lab identifier PCREFID Sample type PCSPEC Sample condition PCSPCCND Not done PCSTAT Reason not done PCREASND |__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| PREDOSE S01 Capillary plasma Venous plasma
|__|__|-|__|__|__|-|__|__|__|__| |__|__|:|__|__| Quantitative Spectrophotometry Carestart Biosensor WST 8/1 assay Other Whole blood Dried |__||__|.|__||__| Per gram hemoglobin APPENDIX E CYP 2D6 GENOTYPING PFCAT=GENETIC VARIATION PFSCAT=GENOTYPE PF Was CYP 2D6 Genotyping performed? PFPERF NOT SUBMITTED Yes No NA Test type PFTEST Gene location PFGENLOC Date of sample PFDAT PFDTC Sample type PFSPEC Sample condition PFSPCCND Not done PFSTAT Reason not done PFREASND Genotype CYP 2D6 |__|__|-|__|__|__|-|__|__|__|__| blood Dried
APPENDIX F ECG RECORDING Was the ECG recorded? EGPERF NOT SUBMITTED Yes No NA111 Date of ECG EGDTC Time of ECG EGTIM EGDTC Method EGMETHOD Position EGPOS Not done EGSTAT Reason not done EGREASND |__|__|-|__|__|__|-|__|__|__|__| 12 Lead standard 12-LEAD STANDARD Sitting SITTING Standing STANDING Supine SUPINE |__|__|:|__|__| ECG TEST RESULTS ECG test name EGTEST Results EGRRES Units EGORRESU Not done EGSTAT Reason not done EGREASND RR-interval RRMEAN_EGORRES MSEC PR-interval |__|__|__| PRMEAN_EGORRES MSEC QT-interval |__|__|__| QTMEAN_EGORRES MSEC QRS-duration |__|__|__| QRSDUR_EGORRES MSEC APPENDIX G MEAL RECORD Was detailed meal record information collected? MLPERF NOT SUBMITTED Yes No NA